MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 1.5MM TI CORTEX SCREW SELF-TAPPING 10MM; SCREW FIXATION INTRAOSSEOUS

Model Number	400.810.96
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient date of birth and weight not available for reporting.Additional product code: mqn.Explanted date: device was not 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.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 head broke off a screw during an open reduction internal fixation (orif) right metacarpal on (b)(6) 2017.Surgeon was inserting the screw in a reasonable manner, using light twisting motions.The shaft and threads of the screw remain in the patient.Surgeon implanted another screw of the same size next to the broken screw.Surgery was delayed approximately 5 minutes.Concomitant devices reported: screwdriver (part number unknown, lot number unknown, quantity unknown).This is report 1 of 1 for (b)(4).

• Brand Name: 1.5MM TI CORTEX SCREW SELF-TAPPING 10MM
• Common Device Name: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7161403
• Report Number: 2939274-2018-50055
• Device Sequence Number: 13906429
• Product Code: DZL
• UDI-Device Identifier: 10886982203700
• UDI-Public: (01)10886982203700(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K981275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2017

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: 400.810.96
• Device Catalogue Number: 400.810.96
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR