MAUDE Adverse Event Report: SYNTHES GMBH REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

Catalog Number 399.99

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was 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 Description

Device report from the (b)(6) reports an event as follows: it was reported that on an unknown date, items were flagged as broken at sterilization, following surgery.This report is for a reduction forceps with serrated jaw-ratchet 144mm.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: part number: 399.99, lot number: t173686, manufacturing site: tuttlingen, release to warehouse date: 07-nov-2018.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.Visual inspection: the reduc-forceps was received with one jaw broken off.There were light scratches along its body consistent with normal wear.No other issues were identified.Dimensional inspection: could not be performed due to post-manufacturing damage.Document/specification review: the returned reduc-forceps was manufactured in november 2018 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities noted.The review of the manufacturing documents has shown that with 1.4021 stainless steel (hardened and tempered) the correct material was used, and that the hardness was within the specification.Summary the complaint condition is confirmed as one of the serrated jaws is broken off.This production lot (t173686) was manufactured in november 2018 according to the specification.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.There were no issues during the manufacture of this product that would contribute to this complaint condition.The damage occurred is determined to be post production/acceptance criteria.Based on the provided (limited) information we are not able to determine the exact cause of this occurrence.However, the damage appears to be the result of unintended forces during use.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.

• Brand Name: REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10634555
• MDR Text Key: 209979668
• Report Number: 8030965-2020-07730
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 07611819028135
• UDI-Public: (01)07611819028135
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 399.99
• Device Lot Number: T173686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FIX-SLEEVE F/STEPPED REAMER; HAND-REAMER F/MEDULL-CANAL Ø8; FIX-SLEEVE F/STEPPED REAMER; HAND-REAMER F/MEDULL-CANAL Ø8