MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS; SCREW, FIXATION, BONE

Model Number	04.005.526
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id also reported as (b)(6).Date of event: date of event is an unknown date in 2020.Device was implanted in (b)(6) 2020.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products: date of concomitant therapy is the same as date of implantation, an unknown date in (b)(6) 2020.Without a lot number the device history records review could not be completed.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.(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 on (b)(6) 2020, patient underwent revision surgery due to nonunion.One (1) titanium (ti) locking screw 36mm, one (1) ti locking screw 28mm, and one (1) ti end cap were removed.One (1) tibial nail and two (2) screws were not removed.Procedure was completed successfully.This report is for a 5.0mm ti locking screw 36mm.This is report 1 of 6 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.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 on october 21, 2020, patient underwent partial removal of one (1) titanium locking screw 36mm, one (1) titanium locking screw 28mm and one (1) titanium end cap due to malunion, revision with tibial rotational osteotomy.One (1) unknown tibial nail and two (2) unknown screws were not removed.The patient outcome was unknown.

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM 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: 10854479
• Report Number: 2939274-2020-05197
• Device Sequence Number: 11379955
• Product Code: HWC
• UDI-Device Identifier: 10886982085948
• UDI-Public: (01)10886982085948
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.005.526
• Device Catalogue Number: 04.005.526
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/14/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM TI LOCKING SCREW 28MM; TI END CAP FOR TIBIAL NAILS; UNK - NAILS: TIBIAL; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR