MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-16 for PLATE CUTTER FOR 1.3MM/1.5MM AND 2.0MM PLATES 03.130.271 manufactured by Wrights Lane Synthes Usa Products Llc.
[188831798]
Reporter is a synthes employee. Part: 03. 130. 271, lot: t155241, manufacturing site: tuttlingen, release to warehouse date: january 23, 2019. A review of the device history records was performed for the finished device lot number and no relevant nonconformance's were found. The final quality release criteria were met before this batch was released for distribution. Visual inspection: the plate cutter for 1. 3mm/1. 5mm and 2. 0mm plates was received at us customer quality (cq). Upon visual inspection, one of the screws is loose since the stakes are broken. The silicone plate holder inserts are also missing. Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage. Document/specification review: current and manufactured revisions were reviewed. No design issues or discrepancies were identified. Investigation conclusion: this complaint is confirmed as a screw is loose since the stakes are broken and the plate holder inserts are missing. No definitive root cause could be determined based on the provided information. No new, unique, or different patient harms were identified as a result of this evaluation. There was no indication that a design or manufacturing issue contributed to the complaint. No design issues were observed during the document/specification review. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. 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
[188831799]
It was reported that during routine incoming inspection of a loaner set on an unknown date, it was observed that the plate cutter was damaged. There was no known patient or hospital involvement. Upon further investigation, it was determined that the device was broken. This report is for a plate cutter. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01294 |
| MDR Report Key | 9836651 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-16 |
| Date of Report | 2020-01-31 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-01-23 |
| Date Added to Maude | 2020-03-16 |
| 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 TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLATE CUTTER FOR 1.3MM/1.5MM AND 2.0MM PLATES |
| Generic Name | INSTRUMENT, CUTTING, ORTHOPAEDIC |
| Product Code | HTZ |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-02-11 |
| Model Number | 03.130.271 |
| Catalog Number | 03.130.271 |
| Lot Number | T155241 |
| 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 | 2020-03-16 |