MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT 1 L46/34 2FLUTE; BIT,DRILL

Catalog Number 513.005

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2020

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.Device is not distributed in the united states, but is similar to device marketed in the usa.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 during the phalanx and metacarpals of the fifth msi fingers surgery performed on (b)(6) 2020, the two (2) drill bits were split while drilling through a grid plate.Broken device was easily removed.A backup device needle k 1.0 was used to complete the procedure.A nail was placed because the fracture was comminuted.There was surgical delay of thirty (30) minutes due to the reported event.No other medical intervention required.The procedure was successfully completed.Concomitant device reported: unknown plate (part #: unknown, lot #: unknown, quantity: 1) this report is for one (1) drill bit ø1 l46/34 2flute.This is report 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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.Part: 513.005, lot: f-26499, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: january 30, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: DRILL BIT 1 L46/34 2FLUTE
• Type of Device: BIT,DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10868629
• MDR Text Key: 231168184
• Report Number: 8030965-2020-09065
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819080997
• UDI-Public: (01)07611819080997
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 513.005
• Device Lot Number: F-26499
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - PLATES