MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/400MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.013.360S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.Investigation summary: 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 history lot: manufacturing location: (b)(4), manufacturing date: mar 27, 2017, expiration date: mar 31, 2026, part number: 04.013.360s, 9mm ti cann retro/antegrade femoral nail ¿ ex/400mm-sterile.Lot number: h324726 (sterile).Lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, inprocess / inspect dimensional / final, 4013 id 324 rev k met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 13563 supplied by ethicon (abq) was reviewed and determined to be conforming.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.Component part(s) reviewed: part number: 21012, tialnbri13.00, lot number: h300859, lot quantity: 3,766 lbs.Certified test report supplied by perryman company dated jan 21, 2016 was reviewed and determined to be conforming.Lot summary report dated feb 05, 2016 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review: oct 08, 2020: dhr reviewed.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) 2020, the patient underwent hardware removal due to nail bent and non-union.The patient was initially implanted with one (1) titanium retro/antegrade femoral nail, and four (4) titanium locking screws (sizes 56mm/85mm/38mm/38mm) on (b)(6) 2018.The patient was supposed to have a planned surgery to lengthen the implant or add another implant for lengthening but the patient did not show up due to personal/family issues so the planned surgery did not push through then it resulted for the nail to fatigue (fail) and bent.The patient was then re-operated and nail exchange was done successfully.The patient was stable after the procedure.Concomitant devices reported: the titanium locking screw with t25 stardrive 56mm f/im nail-sterile (part# 04.005.546s, lot# h246755, quantity 1).Titanium locking screw with t25 stardrive 85mm f/im nail-sterile(part# 04.005.575s, lot# h4982089, quantity 1).Titanium locking screw with t25 stardrive 38mm f/im nail-sterile (part# 04.005.528s, lot# 714447, quantity 1).Titanium locking screw with t25 stardrive 38mm f/im nail-sterile (part# 04.005.528s, lot# h729904, quantity 1).This complaint involves one (1) device.This report is for (1) 9 mm ti cann retro/antegrade femoral nail-ex/400mm-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 9MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/400MM-STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10722056
• Report Number: 2939274-2020-04791
• Device Sequence Number: 11627405
• Product Code: HSB
• UDI-Device Identifier: 10886982087720
• UDI-Public: (01)10886982087720
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: 04.013.360S
• Device Catalogue Number: 04.013.360S
• Device Lot Number: H324726
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Weight: 93