MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 18MM; APPLIANCE,FIXATION,NAIL

Model Number	412.105
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: synthes rep.(b)(4): the reported event required medical/surgical intervention to preclude permanent damage to a body structure.A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 on (b)(6) 2019, the patient was either slipped and fail or drop a 50-pound weight on her wrist and the hardware broke.The surgeon runs the testing on the hardware for the failed hardware.The patient had a wrist fusion plate on an unknown date.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.  concomitant devices reported: unknown screws: trauma (part# unknown, lot# unknown, quantity# unknown).This complaint involves three (3) devices.This report is 3 of 3 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The returned implant was examined, and the complaint condition could be confirmed as a portion of the distal shaft broke off from the screw and was not returned.The head and shaft portion that remains is flush with plate and cannot be removed without the use of force.No other issues were identified with the returned components of the device.Dimensional inspection: a dimensional inspection could not be performed as the screw could not be separated from the plate without causing more damage to the plate and/or screw.Document specification documents were reviewed as part of this investigation: based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Review of the manufacturing record evaluation showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation conclusion: no definitive root cause could be determined, however based on the complaint description the patient either fell or a weight was dropped on wrist causing the screws to break.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history review part: 412.105, lot: l690558, manufacturing site: grenchen, release to warehouse date: 01.December 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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
Updated: concomitant devices reported: unknown screw: trauma (part# unknown, lot# unknown, quantity# 1).Ti lcp wrist fusion standard bend plate (part# 04.110.150, lot# h582221, quantity# 1).3.5mm ti stardrive cortex screw self-tapping 18mm (part# 04.200.018 lot#:l886599, quantity#1).3.5mm ti locking screw slf-tpng with stardrive recess 18mm (part# 412.105, lot# 9396193 , quantity# 1).3.5mm ti locking screw slf-tpng with stardrive recess 18mm (part# 412.105, lot# 9926803 , quantity# 1).3.5mm ti locking screw slf-tpng with stardrive recess 18mm (part# 412.105, lot# l690558 , quantity# 1).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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: 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 18MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8895373
• Report Number: 2939274-2019-59832
• Device Sequence Number: 18914456
• Product Code: KTT
• UDI-Device Identifier: 10886982210388
• UDI-Public: (01)10886982210388
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 412.105
• Device Catalogue Number: 412.105
• Device Lot Number: L690558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 09/04/2019; 09/04/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/04/2019; 09/04/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE; 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE; 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE; 3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING; TI LCP WRIST FUSION STANDARD BEND PLATE; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention