MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM; SCREW, FIXATION, BONE

Model Number	201.766
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight not provided for reporting.Device broke during insertion; device not considered implanted/explanted, partial device (screw) remained in patient.Complainant device is not expected to be returned for manufacturer review/investigation.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.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 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 original surgery for treatment of a left distal radius fracture on (b)(6) 2018, the screw head broke off during insertion into the second most proximal hole of the wrist spanning plate on the radius.The broken screw head was removed and the remaining screw shaft was left in the bone.The surgery was successfully completed with a reported delay of 1 minute.Patient outcome is stable.This complaint is for one (1) device.This report is 1 of 1 for (b)(6).
Additional Manufacturer Narrative
A product investigation was performed.One (1) 2.4mm cortex screw, self-tapping with t8 stardrive recess, 16mm (part 201.766 | lot unknown) was reported with the complaint category of ¿broken (2+ pieces): intraoperatively : rm.¿ however, the device was not returned for investigation; only a picture was provided.Device condition: the provided picture was reviewed.The image shows a screw head with a roughly transverse break located just below the head of the screw.The shown screw head has a round head and shows the edges of a stardrive recess which is consistent the reported device.The threaded shaft of the screw is not shown and reported to remain implanted; thus, the length and threaded features cannot be verified.The complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken and was not received.Lot number review: a dhr review could not be performed as the lot number is unknown.Drawing review: based on the reported part number the relevant drawing was reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.As the physical device was not received dimensional or material testing could not be completed.Conclusion: a device inspection via the provide photo was performed as part of this investigation.The complaint condition is confirmed as the image shows a screw head with a roughly transverse break located just below the head of the screw.No definitive root cause was able to be determined as circumstances surrounding the event are unknown and the device was not returned for physical inspection.From the provided information there is no indication that a design or manufacturing issue contributed to the complaint.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.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.

• Brand Name: 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM
• 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: 7226388
• Report Number: 2939274-2018-50430
• Device Sequence Number: 13682360
• Product Code: HWC
• UDI-Device Identifier: 10886982142764
• UDI-Public: (01)10886982142764(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• 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,Followup
• Report Date (Section B): 01/08/2018

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: 201.766
• Device Catalogue Number: 201.766
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR