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

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

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 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
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7161403
• MDR Text Key: 96706665
• Report Number: 2939274-2018-50055
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 10886982203700
• UDI-Public: (01)10886982203700(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 400.810.96
• Device Catalogue Number: 400.810.96
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 01/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 35 YR