MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8.2 TI ADOL LAT ENTRY FEM NL/400/LT-S; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.031.941S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A review of the device history records has been requested and is currently pending completion.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.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 (b)(6) 2021, patient underwent removal of expert adolescent lateral femoral nail due to infection.Patient outcome was unknown.This complaint involves four (4) devices.This report is for one (1) 8.2 ti adol lat entry fem nl/400/lt-s.This report is 1 of 4 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.H6: a device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 10-feb-2014, expiration date: 31-dec-2022, part number: 04.031.941s, 8.2mm ti adolescent lat entry femoral nail-ex/400mm lt ¿ sterile, lot number: 7591385 (sterile), lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process acceptance, met all inspection acceptance criteria.Inspection sheet, inspect dimensional, met all inspection acceptance criteria.Inspection sheet, final inspection, met all inspection acceptance criteria.Packaging label log lppf, lmd/lpfwas reviewed and determined to be conforming.Packaging bom was reviewed and all components issued met current defined requirements.Scn was reviewed and determined to be conforming.This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component(s) reviewed: part number: 21012, tialnbri13.00, lot number: 7456867, lot quantity: (b)(4).Certified test report supplied by perryman company dated 14-mar-2013 and certificate of test supplied to perryman by howmet castings were reviewed and determined to be conforming.Lot summary report dated 09-aug-2013 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.D7a: unknown.

• Brand Name: 8.2 TI ADOL LAT ENTRY FEM NL/400/LT-S
• 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: 11621680
• Report Number: 2939274-2021-01709
• Device Sequence Number: 14507155
• Product Code: HSB
• UDI-Device Identifier: 10886982094391
• UDI-Public: (01)10886982094391
• Combination Product (Y/N): N
• Initial Reporter State: UT
• PMA/510(K) Number: K070843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 03/09/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 04.031.941S
• Device Catalogue Number: 04.031.941S
• Device Lot Number: 7591385
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8.2MM TI ADLES LAT ENT FMRL NAIL-EX/400MM/LT-STER; UNK - END CAPS: ALFN; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR