MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CANNULATED SCREW PARTIALLY THREADED/50MM; SCREW, FIXATION, BONE

Model Number	214.550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier is unknown.Lot number is unknown.Device malfunctioned intra-operatively and 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.(b)(4).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 during an open reduction internal fixation (orif) of a capitulum fracture on (b)(6) 2018, the surgeon was using a hexagonal screwdriver to insert the cannulated screw when the screw broke at the thread/shaft junction.The screw fragmented when it broke.The surgeon retrieved the larger pieces of the screw, however, the smaller fragments could not be retrieved and were visible under fluoroscopy.Another screw was used to complete the procedure.Surgery was completed successfully, with a reported delay of approximately fifteen (15) minutes.Patient status is stable.Concomitant device: cannulated 3.5mm hexagonal screwdriver (part: 314.20, lot: unknown, quantity: unknown).This report is for a 4.5mm cannulated screw partially threaded/50mm.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM CANNULATED SCREW PARTIALLY THREADED/50MM
• 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: 7630733
• Report Number: 2939274-2018-52591
• Device Sequence Number: 19307525
• Product Code: HWC
• UDI-Device Identifier: 10886982154217
• UDI-Public: (01)10886982154217
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/29/2018

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: 214.550
• Device Catalogue Number: 214.550
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 89