MAUDE Adverse Event Report: SYNTHES SELZACH 1.4MM DRILL BIT/STRYKER J-LTCH WITH 6MM STOP/44.5MM; DRILL, BONE, POWERED

Catalog Number 317.660

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa the investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.Manufacturing location: (b)(4), supplier: (b)(4).Manufacturing date: 12.Dec.2011.No ncrs were generated during production.Review of the device history record(s) showed complaint condition.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 (b)(4) reported an event in (b)(6) as follows: it was reported that a drill bit broke intraoperatively during a scheduled explant surgery.There were no fragments generated and the surgery was successfully completed without any delays.The status of the patient is unknown.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Additional products codes for this report include: erl and hbe.Product investigation summary: one (1) drill bit 1.5mm w/stop was received for investigation.Nearly the entire length of the fluted tip section has broken off (approximately 5mm).Otherwise, the shaft is in good condition apart from slight scratches.Because of the damages, the complaint relevant dimensions could not be checked against specifications.The manufacturing review shows that the production procedure was according to the specifications and that there were no issues that would contribute to this complaint condition.The material used was stainless steel as per requirements and the measured harness was with within the specifications.The broken surface is homogenous, which indicates material conformity.Based on the provided information, the exact cause of this complaint could not be confirmed.A possible reason for the damage could be a metallic contact or with bone material blocking the flutes.For effective chip removal, it is necessary to withdraw the entire drill from the hole at frequent intervals to avoid chip congestion.It is likely that this occurrence, in combination with a mechanical overload situation, caused the breakage.It is important to note that blunt drill bits require more mechanical power during application; therefore, the user should check instruments for sound surfaces, correct adjustment, and function prior to use.Severely damaged instruments should not be used.No indication for product related issue was found.Device 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: 1.4MM DRILL BIT/STRYKER J-LTCH WITH 6MM STOP/44.5MM
• Type of Device: DRILL, BONE, POWERED
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5732224
• MDR Text Key: 47608703
• Report Number: 3000270450-2016-10139
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317.660
• Device Lot Number: F-11016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2011
• 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