MAUDE Adverse Event Report: SYNTHES USA ARTICULATED TENSION DEVICE WITH GAUGE-SPAN 20MM; INSTRUMENT COMPRESSION

Catalog Number	321.12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.No service history review can be performed because the lot/serial number cannot be traced.The manufacture date is unknown.The service history review is unconfirmed.Device history records review was attempted for part# 321.12, lot# 1022.Device history records review is not available as device is older than 20 years.At this time the manufacturing documents for instruments had to be stored for 10 years.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
It was reported that an articulated tension device with gauge-span 20mm (atd) broke off during an initial rotational osteotomy surgery on (b)(6) 2016.The surgeon was tensioning with the atd when he heard a snap, he noticed that the tooth had broken off where it holds onto the plate (95 degree condylar plate 5 holes/60mm/92mm).The piece was retrieved.Another atd was available and the surgeon went on as planned with the case.The plate was not affected in any way and remains implanted in the patient.There was no medical intervention, surgical delay or patient harm.The procedure was completed successfully.Concomitant devices reported: 95 degree condylar plate 5 holes/60mm/92mm (part #237.52, lot # unknown, quantity # 1).This report is for one (1) articulate tension device with gauge-span 20mm.This is report 1 of 1 for (b)(4).

• Brand Name: ARTICULATED TENSION DEVICE WITH GAUGE-SPAN 20MM
• Common Device Name: INSTRUMENT COMPRESSION
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 6233743
• Report Number: 2520274-2017-10093
• Device Sequence Number: 392998
• Product Code: HWN
• UDI-Device Identifier: 10886982190369
• UDI-Public: (01)10886982190369(10)1022
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2016

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: Physician
• Device Catalogue Number: 321.12
• Device Lot Number: 1022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2016
• Initial Report FDA Received Date: 01/09/2017
• 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: PART #237.52, LOT # UNKNOWN, QUANTITY # 1
• Patient Age: 19 YR
• Patient Weight: 50