MAUDE Adverse Event Report: SYNTHES BRANDYWINE COMBINATION T-WRENCH 8MM

Catalog Number	392.969
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement reported.Device history records review was completed for part# 392.969, lot# 4748114.Supplier: (b)(4), release to warehouse date: sep 08, 2004.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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 on (b)(6) 2016, a combination t-wrench 8mm was found broken in the storage facility.No patient involvement was reported.This report is for one (1) combination t-wrench 8mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product development investigation was performed on the returned subject device (combination t-wrench 8mm, part # 392.969, lot # 4748114).The returned combination t-handle wrench is confirmed to be broken.The shaft is broken inside the combination handle.The handle is cracked where the shaft connects, through where the dowel pins are inserted.The balance of the device is in good condition.A visual inspection, drawing review and device history record (dhr) review were performed as part of this investigation.The complaint is confirmed.Replication of the complaint condition is not applicable as the device is already broken.The returned combination t-handle wrench is part of the medium external fixator set with self drilling schanz screws; stainless steel, titanium.The drawings for mm combination wrench were reviewed during investigation.No definitive root cause was able to be determined.There were no issues during the manufacture of this product that would contribute to this complaint condition.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.Date received by manufacturer reported incorrectly on the initial medwatch report-(b)(4).The correct date on the initial medwatch report-(b)(4) should be (b)(6) 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.

• Brand Name: COMBINATION T-WRENCH 8MM
• Common Device Name: WRENCH
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6212489
• Report Number: 2530088-2016-10352
• Device Sequence Number: 1070024
• Product Code: HXC
• UDI-Device Identifier: 10886982198921
• UDI-Public: (01)10886982198921(10)4748114
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2016

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: 392.969
• Device Lot Number: 4748114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2016
• Supplement Report FDA Received Date: 01/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1