MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT 2.5 L110/85 2FLUTE F/QC

Model Number 310.25

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device history lot: part: 310.250, lot: 69p1354, manufacturing site: (b)(4), release to warehouse date: 16.09.2020.A manufacturing record evaluation was performed for the finished device 310.250 lot: 69p1354 and no non-conformance's 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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for an unknown surgery.During the surgery, the drill bit was broken.The surgery was completed successfully without any delay reported.There were no patient consequences.This complaint involves one (1) device.This report is for (1) drill bit ø2.5 l110/85 2 flute.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.H10 additional narrative: the drill bit ø2.5 l110/85 2flute f/qc (product code: 310.250 & lot no: 69p1354) was received at us cq.Upon visual inspection, it was observed that the distal tip of the device cutting feature was broken off.The broken piece was not received.Thus, the complaint condition was confirmed.The overall complaint was confirmed for the received device as a distal tip of the device cutting feature was broken off.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: part: 310.250, lot: 69p1354, manufacturing site: bettlach, release to warehouse date: 16.09.2020.A manufacturing record evaluation was performed for the finished device 310.250 lot: 69p1354 and no non-conformances were identified.Device history batch: null.Device history review: null.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 2.5 L110/85 2FLUTE F/QC
• Type of Device: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10869785
• MDR Text Key: 217447018
• Report Number: 8030965-2020-09080
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10886982186317
• UDI-Public: (01)10886982186317
• 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: 10/25/2020

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 Model Number: 310.25
• Device Catalogue Number: 310.250
• Device Lot Number: 69P1354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Date Manufacturer Received: 03/29/2021
• Patient Sequence Number: 1