MAUDE Adverse Event Report: SYNTHES BETTLACH 1.5MM/1.1MM DOUBLE DRILL SLEEVE; GUIDE

Catalog Number	312.14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportedly there was no patient involvement.Date of event: unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).A device history record (dhr) review was performed for part # 312.140, lot # 8761218: manufacturing location: (b)(4), manufacturing date: 21.Feb.2014: no non conformance reports (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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that parts were detected as damaged during internal inspection of loaner kits.Reportedly there was no patient or procedure involvement.This report is for a 1.5 mm/1.1 mm double drill sleeve that was reportedly broken.This is report 25 of 25 for (b)(4).

• Brand Name: 1.5MM/1.1MM DOUBLE DRILL SLEEVE
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6676740
• Report Number: 9612488-2017-10295
• Device Sequence Number: 13945871
• Product Code: FZX
• UDI-Device Identifier: 10886982187604
• UDI-Public: (01)10886982187604(10)8761218
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/30/2015

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: 312.14
• Device Lot Number: 8761218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2017
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1