MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANNULATED SCREW SHORT THREAD/32MM; SCREW, FIXATION, BONE

Model Number	207.632
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Additional narrative: patient age & weight not provided for reporting.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.Investigation summary: dhr review could not be conducted due the insufficient information¿s.Product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.
Event or Problem Description
It was reported that the thread of a 4.0mm cannulated screw came off as it was being inserted into the bone.This happened during an open reduction internal fixation (orif) of an ankle on (b)(6) 2018.The surgeon was trying the torque feature on a new power drill when this occurred.Fragments were generated from the thread and some of the fragments were left behind in the patient.The surgery was successfully completed without any delay.No additional medical intervention was required to complete the procedure.This complaint involves one (1) device.(b)(4).

• Brand Name: 4.0MM CANNULATED SCREW SHORT THREAD/32MM
• 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: 7395655
• Report Number: 2939274-2018-51431
• Device Sequence Number: 16546076
• Product Code: HWC
• UDI-Device Identifier: 10886982148209
• UDI-Public: (01)10886982148209(10)UNKLOT
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K963192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2018

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: 207.632
• Device Catalogue Number: 207.632
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR