MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 10MM CANNULATED TAPERED DRILL BIT; BIT,DRILL

Catalog Number 03.037.021

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j 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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent surgery using the tfna implants.During the surgery, the surgeon connected the impactor to the guide sleeve and tried to insert the blade, but he could not insert it completely.He tried to insert the blade by hitting the guide sleeve with a hammer, but he was unsuccessful.He removed the blade and inserted it without the guide sleeve and applied the locking mechanism.The surgery was successfully completed with a less-than-30-minute delay.The patient outcome was reported as stable.After the surgery, the surgeon confirmed that the entry part of the blade had been deformed, but it was unknown when it had been deformed.No further information is available.This report is for one (1) 10mm cannulated tapered drill bit.This is report 4 of 4 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: 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.H3, h6: part: 03.037.021, lot: f-17378, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: march 04, 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection the drill bit was received with the reported condition of not proper functioning.The drill bit presents surface wear consistent with use; no further damage was noted.This wear would not affect performance of the device functional test a functional test with the mating instrument (part 03.037.017) was performed and confirmed that there is some resistance noted while assembling.Nevertheless, the assembly could be done.Dimensional inspection not required per selected investigation flow.Document/specification review: the returned drill bit was manufactured in march 2015.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities noted.Summary: the complaint condition (misalignment) could not be confirmed.A function test with the mating instrument revealed some resistance during assembling, but the assembly could be done.The review of the production history revealed that this drill bit was manufactured according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities noted.No manufacturing related issues that would have contributed to this complaint were found; the malfunction occurred is determined to be related to the damage of part 03.037.017.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.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: 10MM CANNULATED TAPERED DRILL BIT
• Type of Device: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10644855
• MDR Text Key: 210407956
• Report Number: 8030965-2020-07795
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819642478
• UDI-Public: (01)07611819642478
• 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: 09/18/2020

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: 03.037.021
• Device Lot Number: F-17378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/13/2020; 11/11/2020
• Supplement Dates FDA Received: 11/06/2020; 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRILLSL YELL; GUIDE SLEEVE YELL; TFNA HELICAL-BLADE IMPACT; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE