MAUDE Adverse Event Report: SYNTHES SELZACH 1.0MM DRILL BIT/K-WIRE ATTCHMTFOR THREADED HOLE/75MM; BIT,DRILL

Catalog Number	03.130.100
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier and weight is not available for reporting.Device is an instrument and is not implanted/explanted.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 an open reduction internal fixation of the first metacarpal a 1.0 mm drill bit from a modular hand system sheared off inside the patient¿s finger.The fragment was retained and was unable to be removed.X-ray taken (b)(6) 2017.Surgery was delayed 3-5 minutes.Procedure was completed successfully and patient outcome was good.This report is for one (1) drill bit.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A device history record review was performed for the subject device lot.Manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 09.May.2016, 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.A product development investigation was performed for the subject device.This complaint is confirmed.The tip of the returned drill bit has sheared off as reported.The transverse break occurred in the cutting/fluted section.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.No new malfunctions were identified as a result of the investigation.A visual inspection under 5x magnification, dimensional inspection of feature(s) related to this complaint, and drawing review were performed as part of this investigation.An accurate measurement of the outside diameter near location of breakage was not able to be obtained at cq due to the damaged edge/surface.The overall length of the returned drill bit measured 67.91 mm (calipers) at cq.Therefore, based on overall length specification of 74.7 mm - 75.3 mm per tabulated drill bit drawing; it is determined that the distal fragment that sheared off would be approximately 7 mm long by 1 mm in diameter.Tabulated drill bit drawing was reviewed during this investigation.No product design issues or discrepancies were observed.Drill bit broke most likely due to very hard bone (first metacarpal bone in (b)(6) male patient).The returned part was determined to be suitable for the intended use when employed and maintained as recommended.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.0MM DRILL BIT/K-WIRE ATTCHMTFOR THREADED HOLE/75MM
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• MDR Report Key: 6460045
• Report Number: 3000270450-2017-10116
• Device Sequence Number: 16262527
• Product Code: HTW
• UDI-Device Identifier: 10886982075215
• UDI-Public: (01)10886982075215(10)F-19008
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.130.100
• Device Lot Number: F-19008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 05/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR