MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-01 for APPLICATION INSTRUMENT FOR STERNAL ZIPFIX 03.501.080 manufactured by Wrights Lane Synthes Usa Products Llc.
[137548683]
Occupation: initial reporter is synthes sales representative. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[137548684]
It was reported that on an unknown date, the application instrument for sternal zipfix malfunctioned and did not allow for the implants to be tightened while tensioning an unknown sternal zipfix. The mechanism itself appears to be broken. The handle cannot be squeezed due to the cutting rod not seating down into position. It is unknown if there was a surgical delay. Procedure outcome and patient status are unknown. Concomitant device reported: unk - zip implants (part# unknown; lot# unknown; quantity unknown); this report is for one (1) application instrument for sternal zipfix. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-56749 |
| MDR Report Key | 8382355 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-01 |
| Date of Report | 2019-02-07 |
| Date Mfgr Received | 2019-03-18 |
| Device Manufacturer Date | 2013-10-10 |
| Date Added to Maude | 2019-03-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | SYNTHES HAEGENDORF GMBH-CN |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAEGENDORF 4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APPLICATION INSTRUMENT FOR STERNAL ZIPFIX |
| Generic Name | APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR |
| Product Code | JDO |
| Date Received | 2019-03-01 |
| Returned To Mfg | 2019-02-14 |
| Model Number | 03.501.080 |
| Catalog Number | 03.501.080 |
| Lot Number | 8652176 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-03-01 |