MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SMALL WIRE CUTTER 230MM; CUTTER,WIRE

Catalog Number 391.940

Device Problem Packaging Problem (3007)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Patient code no code available used to capture the patient¿s unknown surgery.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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 reports an event in (b)(6) as follows: it was reported that on an unknown date, the customer received instrument in loan set was broken and surgeon could not use it during surgery.Surgery delayed 5 mins.Surgery was successful with alternative device and there is no patient harm.This is report 1 for 1 (b)(4).

Manufacturer Narrative

Product complaint # : (b)(4).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.Part returned.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.

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.Mfr site: corrected usa manufacturer information.Reviewing attached picture, the complaint description cannot be confirmed as the device is cracked and not broken as reported.Product was not returned.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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part number: 391.940, lot number: t985252, manufacturing site: tuttlingen, release to warehouse date: feb 11, 2013.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.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 investigation summary the complained part was forwarded to the manufacturing facility for evaluation.Here the statement.The device appears in good condition with some marks of use.The laser welding point on the screw is broken.The pliers are broken/cracked on the cutting edge.The measured relevant features are in specification.The hardening protocol was reviewed and the hardness (48,3 hrc) was according to the specification of the device.The raw material certificate of the broken handle part was reviewed and the used material was according to the specification of the device.The manufacturing evaluation conducted shows that there was no issue during the manufacturing of the product that would contribute to this complaint condition.The exact cause of the broken device cannot be determined.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 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: SMALL WIRE CUTTER 230MM
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9158123
• MDR Text Key: 196545147
• Report Number: 8030965-2019-69059
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819024786
• UDI-Public: (01)07611819024786
• 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,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.940
• Device Lot Number: T985252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR