MAUDE Adverse Event Report: SYNTHES BETTLACH 3.5MM/2.5MM DOUBLE DRILL SLEEVE; GUIDE

Catalog Number	312.28
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: patient information is not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).This part is a class i instrument with product code fzx.As such there is no 510(k) associated.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Manufacturing location: (b)(4); manufacturing date: 12.April 2016.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
Device report from synthes (b)(6) reports an event as follows: it is reported during an open reduction internal fixation (orif) of the ankle on (b)(6) 2017, while surgeon was drilling using the drill sleeve, the drill sleeve broke into two pieces.No pieces fell into the patient and no surgical delay was reported.Procedure was completed with another device with no harm to patient.This report is for one (1) drill guide.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM/2.5MM DOUBLE DRILL SLEEVE
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6517311
• Report Number: 9612488-2017-10188
• Device Sequence Number: 1627726
• Product Code: FZX
• UDI-Device Identifier: 10886982187703
• UDI-Public: (01)10886982187703(10)9856484
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2017

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: 312.28
• Device Lot Number: 9856484
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1