MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM

Catalog Number 03.010.103

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2019

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 at the time of filing this report.A review of the device history records has been requested.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) 2019, a patient underwent an open reduction internal fixation (orif) with the multiloc humeral nailing system for a proximal humeral diaphyseal fracture.During the surgery, it seemed that the drill bit was dull, the surgeon managed to drill for two (2) unknown screws.However, when the surgeon was drilling for the third unknown screw, the drill bit did not move forward after scraping the cortical bone.It was then that the surgeon used another drill bit and completed the drilling without any difficulty.There was no reported surgical delay.The procedure was completed with no adverse consequence to the patient.Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity 3) this complaint involves one (1) device.This report is 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.A review of the device history part: 03.010.103, lot: l427609, manufacturing site: bettlach, release to warehouse date: 20.June 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary: according to the received pictures it cannot be confirmed that the drill bit was dull.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 (information or/and material), 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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d8; e1; h6.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: 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM
• Type of Device: DRILL BIT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8587112
• MDR Text Key: 144710190
• Report Number: 8030965-2019-63575
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819775398
• UDI-Public: (01)07611819775398
• 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: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.103
• Device Lot Number: L427609
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWS.