MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM DRILL BIT W/DEPTH MARK QC/110MM; BIT MILLING STERILE AND NON

Catalog Number 310.534

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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 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 (b)(6) reports an event as follows: it was reported that on unknown date the patient underwent a surgery with variable angle (va) foot system.The surgeon found that the drill bit had been broken.It was not reported whether it was before or during the surgery when he found the breakage.This report is for one 2.0mm drill bit w/depth mark qc/110mm.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.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: 310.534, lot: 3l31533, manufacturing site: bettlach, release to warehouse date: february 07, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the visual inspection of the returned drill bit has shown that the shaft is bent but not broken as reported.The instrument is all in all in very used condition and there are clearly wear marks and scratches on the cutting edges visible.Dimensional inspection: due to the jammed parts, the relevant dimension could not be measured.However, the parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Document/specification review: the material was reviewed and the hardness value was confirmed to meet the specification with no non-conformance noted.The measurements of the hardness after the hardening procedure were also within the specification.Summary: the visual inspection of the returned drill bit has shown that the shaft is bent but not broken as reported.This lot was manufactured in february 2019, according to the specification.There were no issues during the manufacture of this product that would contribute to this complaint condition.Unfortunately, we are not able to determine the exact cause which has led to the bent shaft, we can only assume that high force or lateral stress has caused the breakage.We also would like to draw your attention on page 4 in the leaflet ¿important information¿: check instruments for sound surfaces, and correct adjustment and function.Do not use severely damaged instruments, instruments with unrecognizable markings, corrosion, or blunt cutting surfaces.Based on the manufacturing investigation results we conclude that the cause of failure is not due to any manufacturing non-conformances.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: 2.0MM DRILL BIT W/DEPTH MARK QC/110MM
• Type of Device: BIT MILLING STERILE AND NON
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9722385
• MDR Text Key: 191467660
• Report Number: 8030965-2020-01208
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 07611819158962
• UDI-Public: (01)07611819158962
• 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: 01/28/2020

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: 310.534
• Device Lot Number: 3L31533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 02/17/2020; 03/17/2020
• Supplement Dates FDA Received: 03/16/2020; 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1