MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0 TI LCKNG SCR T25 SD 34 FOR IM NAILS; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.005.424
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional pro-code: hwc complainant device 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: product was not returned.Based on the information available, it has been determined that no corrective and 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 on an unknown date, the patient underwent removal of titanium cannulated tibial nail with proximal bend and six (6) titanium locking screws due to nonunion.All hardware was successfully removed intact.The reamer irrigator aspirator (ria) 2 reamer head broke off during reaming.Patient outcome was unknown.This (b)(4) captures the postop event removal, due to nonunion.(b)(4) captures the intra-op event during removal when the reamer head broke off.This complaint involves seven (7) devices.This report is for one (1) 4.0 ti lckng scr t25 sd 34 for im nails.This report is 1 of 7 for (b)(4).

• Brand Name: 4.0 TI LCKNG SCR T25 SD 34 FOR IM NAILS
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11802917
• Report Number: 2939274-2021-02278
• Device Sequence Number: 19969640
• Product Code: HSB
• UDI-Device Identifier: 10886982085368
• UDI-Public: (01)10886982085368
• Combination Product (Y/N): N
• PMA/510(K) Number: K103002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2021

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: 04.005.424
• Device Catalogue Number: 04.005.424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 64