MAUDE Adverse Event Report: SYNTHES SELZACH 1.1MM DRILL BIT/MQC FOR THREADED HOLE/56MM; BIT, DRILL

Catalog Number 03.130.202

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient age was reported as (b)(6).Device is an instrument and is not implanted/explanted.Device history record review concluded that no non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing site was: (b)(4), supplier: (b)(4) and manufacturing date: 27.May 2016.Subject device has been received; no conclusions could be drawn and the product evaluation is still in progress.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

It was reported that during an open reduction internal fixation (orif) of the fifth metacarpal on (b)(6) 2016, the drill bit broke in half when surgeon was drilling.The surgeon was able to retrieve the half and other half still remained in the patient.There was no reported surgical delay or patient harm.The surgery was completed successfully and the patient was reported as stable at the end of the procedure.This is report number 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the drill bit (part number 03.130.202, lot number f-19741).The subject device was returned with the complaint condition stating the drill bit was received with the distal tip sheared off; the distal portion was not returned for evaluation.The complaint was confirmed.Device history record (dhr) review, visual inspection, functional test, drawing review, complaint history review, and risk assessment review were performed as part of this investigation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition.The as received length of the returned broken drill bit measures approximately 49.0mm, therefore the sheared off fragment would be approximately 6.95mm in length using product drawing as reference.The balance of the device is in good functional condition.A review of the current design drawing was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No definitive root cause was able to be determined as circumstances surrounding the event are unknown.The condition is condition with exposure to exceeding forces which can be the result of too much pressure exerted and/or off axis pressure.This would be exacerbated if using a dull/worn drill bit.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.1MM DRILL BIT/MQC FOR THREADED HOLE/56MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6155990
• MDR Text Key: 61849704
• Report Number: 3000270450-2016-10294
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.130.202
• Device Lot Number: F-19741
• Other Device ID Number: (01)10886982075338(10)F-19741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 96