MAUDE Adverse Event Report: SYNTHES SELZACH 1.0MM DRILL BIT/STRYKER J-LTCH 1.0MM DRILL BIT/STRYKER J-LTCH; BIT,DRILL

Catalog Number	316.447
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient id, dob & weight not provided for reporting.Device is an instrument and is not implanted/explanted.Device is not expected to be returned to synthes manufacturer for evaluation /investigation.(b)(4).Device history records review was conducted, dhr review for: part #316.447 / 421157, manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 16.Dec.2008.No ncrs 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.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
Device report from synthes on an event in (b)(6) as follows: it was reported that the reported drill tip was broken during the plate fixation of mandible angle.The screw was broken during the plate fixation of median part.The surgeon was aware that the products were not recommended to use for mandible bone.However, the customer says excessive force was not applied during the usage.Currently the brain contusion is severe, and the patient is being intubated.No x-ray was shot since the incident, and the broken fragments are being remained in the patient¿s body.When the incident occurred, the nurse told sales reps that only screw was broken, so the broken drill was not taken out of the patient¿s body.The hospital opinions that the products exceeded the limit for the number of times of sterilization, however the customer says that limitation is not stated clearly by the manufacture.There is no information available about surgical outcome.There was no surgical prolongation reported.This complaint involves 2 parts.Concomitant device: 1x unk screwdriver.This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Additional device product codes: dzi erl hbe.Reporter phone number: (b)(6).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.
Additional Manufacturer Narrative
Additional narrative: a manufacturing investigation action was conducted/performed.The report indicates that the: drill bit returned with broken tip section 1x drill bit article 316.447 with lot sent 421157 was sent to supplier sphinx for investigation: statement supplier sphinx: we have now received the broken drill from the heat treatment company studer, including the hardening-certificate of the investigated drill, as well as the original hardening-certificate dating back to 15.07.2008, when the raw material for manufacturing this drill has been heat-treated.Also in the attachment, you will find the original documents of part.82294/316.447 with lot-no.421157, which have been sent to synthes accompanying the goods.According to these certificates, there is no evidence to be found that this drill was not hardened according to the specifications, and therefore we will not take responsibility that this drill could break during an operation.We will send this affected drill back to you, together with the certificates and documents mentioned in this report.Conclusion: complaint is confirmed as this drill bit is broken but supplier sphinx did not found any manufacturing related failures.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: 1.0MM DRILL BIT/STRYKER J-LTCH 1.0MM DRILL BIT/STRYKER J-LTCH
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• MDR Report Key: 6197490
• Report Number: 3000270450-2016-10303
• Device Sequence Number: 18926567
• Product Code: HTW
• UDI-Device Identifier: 10887587038056
• UDI-Public: (01)10887587038056(10)421157
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2016

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: 316.447
• Device Lot Number: 421157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 01/19/2017; 02/13/2017
• 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: 1X UNK SCREWDRIVER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR