MAUDE Adverse Event Report: SYNTHES BETTLACH ENDPIECE WITH DOUBLE JOINT; TRACTION, APPARATUS, NON-POWERED

Catalog Number	394.44
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no reported patient involvement.Device is an instrument and is not implanted/explanted.No service history review can be performed as part number 394.44 with lot number(s) 9399827 is a lot/batch controlled item.The manufacture date of this item is unknown.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Manufacturing location: (b)(4).Manufacturing date: june 01, 2015.No non-conformance reports 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 service and repair evaluation was completed: the customer reported the chain was broken.The repair technician reported damaged component as the reason for repair.The cause of the issue is unknown.The following parts were replaced: chain & connecting cotter pin.The item was repaired per the inspection sheet, passed synthes final inspection and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.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 an evaluation endpiece instrument was found to have a broken chain.The issue was identified during auditing activities of the evaluation set; there were no issues reported by the customer; no patient involvement was reported.This is report 1 of 1 for com-(b)(4).

• Brand Name: ENDPIECE WITH DOUBLE JOINT
• Common Device Name: TRACTION, APPARATUS, NON-POWERED
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6205135
• Report Number: 9612488-2016-10527
• Device Sequence Number: 993600
• Product Code: HST
• UDI-Device Identifier: 10886982199720
• UDI-Public: (01)10886982199720(10)9399827
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2016

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: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 394.44
• Device Lot Number: 9399827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2016
• Initial Report FDA Received Date: 12/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1