MAUDE Adverse Event Report: SYNTHES BETTLACH SILICONE HANDLE QUICK COUPLING/LONG; MISC ORTHO SURGICAL INSTR

Catalog Number	03.111.012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: there was no known reported patient involvement associated with the complained event.Date of event is unknown.Device is an instrument and is not implanted/explanted.A device history record review was performed for part #03.111.012, lot #2550624: manufacturing location: (b)(4), manufacturing date: 20-jan-2010: 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.A product development investigation was performed for the subject device (silicone handle quick coupling/long, part #03.111.012, lot #2550624.The subject device was received at customer quality (cq) in two pieces.The nosepiece/coupling is separate from the remainder of the device.The pin that secures the coupling to the device has sheared off and a portion of the pin remains in the device and a portion of the pin is no longer present.Because the pin is circumferentially laser welded to the device and has sheared in half, the failure code of "broken : procedural step unknown" was selected for this investigation summary to account for the pin breaking.This complaint condition was likely caused by over 6 years of use and possible rough handling during surgery or sterile processing.However, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, functional test, dhr review and drawing review were performed as part of this investigation.This complaint is confirmed.Whether this complaint can be replicated is not applicable as the pin is already broke.Drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.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
It was reported that during inspection at the metro office it was noticed the silicone handle quick coupling/long would no longer lock into place properly.There was no surgery or patient involvement.During the manufacturer investigation process it was identified that the returned silicone handle quick coupling/long is broken in two pieces.The nosepiece/coupling is separate from the remainder of the device.The pin that secures the coupling to the device has sheared off and a portion of the pin remains in the device and a portion of the pin is no longer present.This condition was re-evaluated and determined to be reportable on december 9, 2016.This is report 1 of 1 for (b)(4).

• Brand Name: SILICONE HANDLE QUICK COUPLING/LONG
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6169920
• Report Number: 9612488-2016-10506
• Device Sequence Number: 19100320
• Product Code: LXH
• UDI-Device Identifier: 10886982072115
• UDI-Public: (01)10886982072115(10)2550624
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2016

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: 03.111.012
• Device Lot Number: 2550624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2016
• Initial Report FDA Received Date: 12/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1