MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BENDING/CUTTING PLIERS; PLIERS, SURGICAL

Catalog Number 391.962

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a synthes employee.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.

Event Description

Device report from synthes (b)(6) reports an event as follows: it was reported that on an unknown date, the patient underwent a surgery.During the surgery, a bit of the pliers broke.The fragment might have remained in the body.No further information is available.This report is for a bending/cutting pliers.This is report 1 of 1 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.E3: reporter is synthes sales consultant.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.

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, h4, h6: part number: 391.962 lot number: t155562, manufacturing site: tuttlingen, release to warehouse date: january 30, 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 investigation: the visual investigation has shown that one carbide insert tip of bending/cutting pliers is broken off.The second carbide insert has slight damaged of the knurled gripping surface.The surface near pivotal point of the bending/cutting pliers has some marks and dent visible as well at the tip.The article is in a used condition.Dimensional inspection: because of the damages, the complaint relevant dimensions cannot be checked to print specifications anymore.However, the parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Document/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused, use-related damage at the device, therefore no document/specification review is needed.Material 1.4021 was used, and the hardness value was confirmed to meet the specification with no non-conformance noted.Conclusion: the received condition agrees with the complaint description and the complaint therefore is confirmed.We do suppose that the device encountered unintended forces, such as excessive force application during use which finally caused the post manufacturing damages.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 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: BENDING/CUTTING PLIERS
• Type of Device: PLIERS, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8893545
• MDR Text Key: 154419130
• Report Number: 8030965-2019-67231
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 07611819072732
• UDI-Public: (01)07611819072732
• 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,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.962
• Device Lot Number: T155562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention