MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRILL BIT 1 L46/34 2FLUTE

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 10/10/2020

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, 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 on (b)(6) 2020 during an unknown surgery, the drill bit broke.There was no patient consequence.The procedure was successfully completed.This report is for one (1) drill bit ø1 l46/34 2flute.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h4, h6: the complaint product is not available to return.The customer retaining the product.Device history lot part: 513.005 lot: f-25416 manufacturing site: selzach supplier: (b)(4).Release to warehouse date: (b)(6) , 2018 a manufacturing record evaluation was performed for the finished device lot number, 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.

• Brand Name: DRILL BIT 1 L46/34 2FLUTE
• Type of Device: DRILL BIT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10804826
• MDR Text Key: 215340702
• Report Number: 2939274-2020-05003
• 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: 10/10/2020

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: 513.005
• Device Lot Number: F-25416
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 11/10/2020
• Supplement Dates FDA Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR