MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 4.5MM CANNULATED SCREW PARTIALLY THREADED/40MM; SCREW, FIXATION, BONE

Model Number	214.540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: patient weight is unknown.Device broke during insertion; device was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 the threads broke off a 4.5 mm cannulated screw (length: 40 mm) during a patella repair procedure.Screw removed but some pieces remained in patella.Procedure was completed successfully with no delay in surgery.(b)(4).

• Brand Name: 4.5MM CANNULATED SCREW PARTIALLY THREADED/40MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7207324
• Report Number: 2939274-2018-50324
• Device Sequence Number: 1277089
• Product Code: HWC
• UDI-Device Identifier: 10886982154163
• UDI-Public: (01)10886982154163(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K963172
• 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): 12/23/2017

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 Model Number: 214.540
• Device Catalogue Number: 214.540
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2017
• Initial Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR