MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-08 for TI MATRIXNEURO SCREW SELF-DRILLING 4MM 04.503.104.01 manufactured by Wrights Lane Synthes Usa Products Llc.
[110579528]
Patient information not available for reporting. Additional product codes: jey, gxr. Device malfunctioned intra-operatively and was not implanted / explanted. A product investigation was conducted. The returned titanium matrix neuro screw (04. 503. 104. 01) is part of the matrix neuro cranial plating system and matrix neuro cranial plating next generation system intended for use in selective trauma of the midface and craniofacial skeleton. Customer quality investigation: at customer quality, the returned 4 mm ti matrix neuro screw self-drilling (part: 04. 503. 104. 01, lot: unk, mfg: unk) was inspected and the complaint was confirmed. The following investigations were performed: broken and damage: visual (appearance not as expected): visual inspection performed at customer quality under 10x magnification observed that the returned screw? S distal self-drilling tip appears to be broken off. Also, screw threads were observed to be worn and slightly nicked which is consistent with attempted insertion and removal. No new issues were identified with the remaining portions of the returned device except for the screw driver usage marks on the head portion of the screw which does not affect the device functionality. The received condition agrees with the complaint description and the complaint was confirmed. The lot number for the returned screw was unavailable, therefore its date of manufacture could not be determined, and a dhr review could not be completed. Relevant drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended. Relevant drawings for the returned device (both current and from the time of manufacture) were reviewed. Dimensional analysis performed on the screw length measured and it falls out of the specification per relevant drawing. The out of specification is due to the post manufacture damage. A material test was not attempted on the returned material as accurate measurement will not be obtained due to the small features of the screw. While it is not possible to determine a definitive root cause for the complaint condition based on the available information, a precaution does exist in the surgical technique guides and to pre-drill in particularly dense / hard bone using 1. 1mm drill bit and to not exceed 1,800 revolutions per minute (rpm) when using 5mm screws. Although the returned screw is a 4mm screw, if it was used on unusually dense bone, stress from the resulting forces could have contributed to the complaint condition. Therefore, due to the small features of the returned screw which makes its susceptible to incorrect screwing and with the given precautions in the technique guides, it is more likely that operational challenges contributed to the complaint condition, rather than a screw material deficiency. During the investigation, no unidentified product design or manufacturing issues or discrepancies were observed that may have contributed to the complaint condition. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[110579529]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the tip of two (2) separate matrixneuro screws broke off during an unknown surgical procedure on (b)(6) 2018 and also two (2) separate matrixneuro screws would not thread. Product did come in contact with the patient, no patient harm was reported. During manufacturer? S investigation of the returned device it was observed that returned screw? S distal self-drilling tip appears to be broken off. Also, screw threads were observed to be worn and slightly nicked which is consistent with attempted insertion and removal. This condition was re-evaluated and determined to be reportable on (b)(6) 2018. This report is for one (1) matrixneuro screw. This is report 3 of 3 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-52441 |
| MDR Report Key | 7583833 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-08 |
| Date of Report | 2018-03-12 |
| Date of Event | 2018-03-07 |
| Date Mfgr Received | 2018-06-08 |
| Date Added to Maude | 2018-06-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI MATRIXNEURO SCREW SELF-DRILLING 4MM |
| Generic Name | PLATE,CRANIOPLASTY,PREFORMED,ALTERABLE |
| Product Code | GWO |
| Date Received | 2018-06-08 |
| Returned To Mfg | 2018-05-31 |
| Model Number | 04.503.104.01 |
| Catalog Number | 04.503.104.01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-08 |