MAUDE Adverse Event Report: SYNTHES BRANDYWINE LCP® DHHS(TM) COUPLING SCREW 324MM; MISC ORTHO SURGICAL INSTR

Catalog Number	338.345
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted / explanted.Device history records review was completed for part# 338.345, lot# 5101250.Manufacturing location: (b)(4), release to warehouse date: feb 02, 2002.No non conformance reports were generated during production.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 while putting a tray of devices back in the sterile processing room, the lcp® dhhs(tm) coupling screw 324 mm was discovered to be damaged.The threads of the device were broken off at the end of the coupling screw.That piece had broken off and was disposed of at the hospital.There were no other broken pieces.There was no patient involvement.This report is for one (1) lcp® dhhs(tm) coupling screw 324 mm.This is report 1 of 1 for com-(b)(4).
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A product development investigation was performed for the coupling screw (part number 338.345, lot number 5101250).The subject device was returned with the complaint condition stating distal threaded tip has sheared off mid-thread and was not returned for evaluation.Only 1-2 partial threadforms remain on the returned device.The complaint is confirmed.The length of the remaining shaft portion of the returned device measures approximately 193.0 mm.Therefore, the sheared off tip fragment would be approximately 6mm in length with reference to length specification of 298.8 - 299.2mm per product drawing.The inside diameter nearest the break measured 2.61mm which is within specification of 2.58mm - 2.65mm per product drawing.An accurate measurement of the outside minor thread diameter could not be obtained during this investigation due to the damage.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.No non-conformance records (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 root cause was not able to be determined.The most probable cause is likely do to application of excessive off-axis force resulting in the tip to shear off as it is the location of least matierial cross section for the device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCP® DHHS(TM) COUPLING SCREW 324MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6219285
• Report Number: 2530088-2017-10000
• Device Sequence Number: 10878821
• Product Code: LXH
• UDI-Device Identifier: 10886982193407
• UDI-Public: (01)10886982193407(10)5101250
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup,Followup
• Report Date (Section B): 12/08/2016

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: 338.345
• Device Lot Number: 5101250
• 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: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 01/19/2017; 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1