MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-04-23 for 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM 212.104 manufactured by Synthes Usa.
[10743004]
Device is used for treatment, not diagnosis. Device received for evaluation the 9-hole stainless steel wrist fusion plate is designed to be manufactured of implant quality 316l stainless steel, per astm f138. The holes and hole locations are dimensioned appropriately for the associated indications, and are standard 3. 5mm and 2. 7mm synthes combi holes. The plate is also designed to be adequately thick for the associated indications, and the electropolish finish is per synthes standard. The packaging, labeling, and sterilization are per synthes standards, and a technique guide exists to explain proper implantation of the plate. All the screws are designed to be manufactured of implant quality 316l stainless steel, per astm f138. They are designed of the correct diameter - 2. 7mm and 3. 5mm screws - and the heads of the screws are standard 3. 5mm and 2. 7mm synthes locking threads. The head of the cortex screw is appropriately dimensioned to fit in the non-locking portion of the combi hole. The packaging, labeling, and sterilization are per synthes standards, and a technique guide exists to explain proper implantation of the screws. No other design factor could have contributed to the failure of the device. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[21655534]
Patient was implanted with lcp wrist fusion straight plate and screw construct on (b)(6) 2012. X-ray taken on an unknown date revealed a non-union. Reportedly the patient was not complaint of pain. Patient was returned to the or on (b)(6) 2013 and the patient underwent a revision of the right wrist fusion. The surgeon removed the plate and screws. It was reported two 2. 7mm locking screws had the heads broken off and the remaining part of the two screws were left in the patient (possibly 14 to 16 mm) in the 3rd metacarpal. Patient was revised with an 8 hole, 3. 5 locking plate and 8 screws (4 locking screws and 4 cortical screws). Reportedly the procedure was completed as planned. This is 6 of 8 reports for the same event, (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21904285]
Device was used for treatment, not diagnosis. Additional product code: hwc. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-02077 |
| MDR Report Key | 3072250 |
| Report Source | 05,07 |
| Date Received | 2013-04-23 |
| Date of Report | 2013-03-26 |
| Date Mfgr Received | 2013-04-25 |
| Date Added to Maude | 2013-04-23 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. SARMA PIN |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM |
| Product Code | HTT |
| Date Received | 2013-04-23 |
| Returned To Mfg | 2013-04-25 |
| Catalog Number | 212.104 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | WEST CHESTER PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-23 |