MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 6MM/9MM CANNULATED STEPPED DRILL BIT; BIT,DRILL

Catalog Number 03.037.022

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

Returned for manufacturer review/ investigation.Reporter is a synthes rep.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that the reamer appeared to get caught on the guide wire and the end sheared off approx.2 mm piece.The surgeon stopped and removed all the relating equipment and carried on with the manual tap.The fragment was left in the patient and the surgeon felt this was not an issue.This complaint involves two (2) devices.This report is for one (1) 6 mm/ 9 mm cannulated stepped drill bit.This report is 1 of 2 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 tip of the stepped reamer is broken as complained.The complete cutting tip section has broken off and fragments were not returned for investigation.Besides, the instrument presents normal signs of use.The complaint condition is confirmed as the tip of stepped reamer is broken.Per the event description the fragments were not removed.This production lot (f-22667) was manufactured in october 2017 according to the specification.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The correct material was used, and the hardness parameters were within the specifications.There were no issues during the manufacture of this product that would contribute to this complaint condition.The damage occurred is determined to be post production/acceptance criteria.It was reported that the reamer appeared to get caught on the guide wire and the end sheared off.Based on this provided information, we assume that a blockage in combination with too much mechanical force caused the breakage of the reamer.Therefore, we can confirm the visible damages are not from any manufacturing non-conformity.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part: 03.037.022, lot: f-22667, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 23.Oct.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.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: 6MM/9MM CANNULATED STEPPED DRILL BIT
• Type of Device: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9438093
• MDR Text Key: 170033464
• Report Number: 8030965-2019-70921
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819642485
• UDI-Public: (01)07611819642485
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.022
• Device Lot Number: F-22667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 12/17/2019; 02/10/2020
• Supplement Dates FDA Received: 01/10/2020; 02/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention