MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH FLAG PELVIC OSTEOTOME 20MM

Catalog Number	03.100.307
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the tip of the pelvic osteotome was found to be bent.The damaged pelvic osteotome was found prior to a scheduled operation.There is no patient involvement.This report involves one (1) flag pelvic osteotome 20mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h6: investigation summary of the manufacturing evaluation: the returned device has damages (pressure points) at the tip near the cutting edge and the complaint condition is confirmed.This lot was manufactured in june 2019 according to the specification.There were no issues during the manufacture of this product that would contribute to this complaint condition.Unfortunately the exact cause of the damages on the tip cannot be determined, the damage was probably caused during the transport of the device.Based on the manufacturing investigation results we conclude that the cause of failure is not due to any manufacturing non-conformance's.The manufacturing evaluation conducted shows that there was no issue during the manufacturing of the product that would contribute to this complaint condition.No manufacturing issues was found during investigation, therefore no prm documents were reviewed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot part number: 03.100.307 lot number: t184488 manufacturing site: tuttlingen release to warehouse date: jun 12, 2019 a review of the device history records was performed for the finished device lot number, and no non-conformance's were identified.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.

• Brand Name: FLAG PELVIC OSTEOTOME 20MM
• Common Device Name: OSTEOTOME
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9915568
• Report Number: 8030965-2020-02548
• Device Sequence Number: 2496747
• Product Code: HWM
• UDI-Device Identifier: 07611819483392
• UDI-Public: (01)07611819483392
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.100.307
• Device Lot Number: T184488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PELVIC OSTEOTOME FLAG-SHAPED 20