MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 54MM FOR IM NAILS; SCREW, FIXATION, BONE

Model Number	04.005.532
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt info: this information is unknown.It is unknown when device broke.Lot number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.(b)(4).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 patient was implanted with one (1) titanium cannulated retro/antegrade femoral nail and four (4) 5.0 mm titanium locking screws on (b)(6) 2017.On (b)(6) 2018, the surgeon presented an x-ray images showing non-union of the right mid femur shaft.One of two proximal screws was broken and one of the two distal screws was broken.On (b)(6) 2018, the patient underwent hardware removal and plate fixation.The surgeon removed the femoral nail, along with three (3) complete locking screws, and the lateral half of the most proximal screw.The surgeon left the medial portion of the most proximal locking screw implanted and did not attempt to remove it.Patient was revised to a plate and screws.The procedure lasted approximately 3 hours and was completed successfully.Patient outcome is unknown.Concomitant devices: 10 mm titanium cannulated retro/antegrade femoral nail 400 mm (part: 04.013.460s, lot: 5599032, quantity: 1).5.0 mm titanium locking screw 38 mm (part: 04.005.528, lot: unknown, quantity: 1).The 5.0 mm titanium locking screw 50 mm (part: 04.005.540, lot: unknown, quantity: 1).This report is for a 5.0 mm ti locking screw w/t25 stardrive 42 mm for im nails.This is report 2 of 2 for (b)(4).
Event or Problem Description
Concomitant devices reported: 10mm cannulated retrograde/antegrade femopral nail ¿ ex 400mm (04.013.460s, lot 5599032, quantity 1), 5.0mm locking screw with t25 stardrive 48mm for im nails (04.005.538, lot number unknown, quantity 1), 5.0mm locking screw with t25 stardrive 78mm for im nails (04.005.568, lot number unknown, 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.Subject device has been received and is currently in the evaluation process.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.
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.510k: this report is for an unknown 5.0mm titanium locking screw 48mm.Part and lot numbers are unknown; udi number is unknown.G1: physical manufacturer is unknown.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
Concomitant medical devices: 10mm titanium cannulated retro/antegrade femoral nail 400mm (part: 04.013.460s, lot: 5599032, quantity: 1) 5.0mm titanium locking screw 38mm (part: 04.005.528, lot: unknown, quantity: 1).5.0mm titanium locking screw 72mm (part: 04.005.562, lot: unknown, quantity: 1).This report is for an unknown 5.0mm titanium locking screw 48mm.
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.A product investigation was conducted.Device condition: visual inspection performed at customer quality (cq) on the returned screw observed the screw to be broken approximately about its midsection.The break was observed to be transverse, however the breakage was shifted downwards at half way along the mid shaft axis.The broken portions were returned, and the breakage pattern was observed to be due to possible unintended forces on the screw.No new issues were noted on rest of the portions of the returned screw.Dimensional analysis and document/specification review: as the manufacture date was unknown exact drawing the device made to was not able to be identified.However, all revision drawings of the device were reviewed, and no design issues were identified.Dimensional inspection performed on the diameter at the broken portion measured the and it falls within the specification per relevant drawings.Review of the device history record was not able to be performed as lot number was unknown.However, upon visual inspection at the broken portions no material irregularities or voids were observed.Therefore, the given material was not observed to be contributing the given complaint condition.Conclusion: the overall given complaint condition is confirmed.While the root cause for the given complaint was not able to be determined, it is possible that any unintended forces on the device could have contributed to screw breakage.During the investigation no product design issues or manufacturing 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.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
This report is for one (1) 5.0mm ti locking screw w/t25 stardrive 54mm for im nails.

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 54MM FOR IM NAILS
• 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: 7698747
• Report Number: 2939274-2018-52961
• Device Sequence Number: 19270840
• Product Code: HWC
• UDI-Device Identifier: 10886982086006
• UDI-Public: (01)10886982086006
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/26/2018

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: 04.005.532
• Device Catalogue Number: 04.005.544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 07/18/2018; 08/23/2018; 08/20/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 07/30/2018; 08/23/2018; 09/19/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6) 2017; SEE DESCRIPTION, THERAPY DATE: (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention