MAUDE Adverse Event Report: SYNTHES BRANDYWINE DRILL STOP; GUIDE

Catalog Number	357.405
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: no reported patient involvement.Date of event is unknown.Device is an instrument and is not implanted/explanted.Therapy date of concomitant device is unknown.Manufacturing location: supplier (b)(4).Manufacturing date: 05-sep-2008.Part #: 357.405, lot#: 5764155 (non-sterile) - drill stop quantity (b)(4), no nonconformances were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 or Problem Description
It was reported that during routine inspection, five devices were identified to be not working properly.There was no patient involvement.Torque limiting attachment was not holding drive shaft, handle for torque limiting attachment was missing set screw, interlocking bolt had threads heavily damaged and will not engage into plate, cannulated stepped drill bit had tip sheared off and will not go over guide wire and the tip was broken, drill stop will not stop and slides on drill.The plate was working fine.Concomitant devices reported: plate (part # unknown, lot # unknown, quantity # 1), guide wire (part # 357.399, lot # unknown, quantity # 1), drill (part # 357.403, lot # unknown, quantity # 1).This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Product investigation has been completed.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.This complaint is confirmed.Visual inspection at cq confirmed that one of the leading edges on the cannulated stepped reamer distal tip has a sheared off, and the drill stop does not slide or stop as intended on the returned stepped reamer.The complaint condition for the drill stop was able to be replicated at cq with the returned stepped reamer.Relevant drawings were reviewed.No product design issues or discrepancies were observed.We were unable to determine root cause.Likely due to over 8 years of continuous use.No new, unique or different patient harms were identified as a result of this evaluation.The returned parts were determined to be suitable for the intended use when employed and maintained as recommended.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 STOP
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6336080
• Report Number: 2530088-2017-10045
• Device Sequence Number: 16420483
• Product Code: FZX
• UDI-Device Identifier: 10886982196286
• UDI-Public: (01)10886982196286(10)5764155
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 357.405
• Device Lot Number: 5764155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 03/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRILL (PART # 357.403, LOT # UNK, QTY # 1); GUIDE WIRE (PART # 357.399, LOT # UNK, QTY1); PLATE (PART # UNK, LOT # UNK, QTY# 1)