MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTION HOOK FOR TI CANNULATED NAILS; EXTRACTOR

Catalog Number 355.399

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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, during the incoming inspection, at the hospital, it was noticed that the instrument was bent.The instrument was not put in use.No surgery or patient was affected.This report involves one (1) extraction hook for ti cannulated nails.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.H3, h4, h6- the extraction-hook was returned sealed, still in the original packaging.The visual inspection has shown that the extraction-hook is bent at the shaft region.The tip of extaction-hook is bent according to the specification.There are no other visible damages at the device.It was unpacked for evaluation and measuring.The received condition of the device is concordant with the complaint description and the complaint condition is therefore confirmed.Unfortunately, we are not able to determine the exact cause of this complaint.We only can assume that the bending occurred trough out a storage or transport issue.During this 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 history lot part number:355.399, synthes lot number:u348375, supplier lot number: n/a, release to warehouse date: 13feb2020, expiration date: n/a, supplier: (b)(4).The product was dispositioned as returned to vendor.This non-conformance is not relevant to the complaint condition.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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: EXTRACTION HOOK FOR TI CANNULATED NAILS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10592847
• MDR Text Key: 208759153
• Report Number: 8030965-2020-07479
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819709560
• UDI-Public: (01)07611819709560
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

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: 355.399
• Device Lot Number: U348375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 11/02/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1