MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.158S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event year is reported as 2020; however exact date of event is unknown.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.A device history record (dhr) review was conducted: manufacturing location: (b)(4).Manufacturing date: jan 18, 2020.Expiration date: dec 31, 2029.Part number: 04.037.158s, 11mm/130 deg ti cann tfna 380mm/right- sterile.Lot number: 36p1023 (sterile).Lot quantity: 6.Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 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: 04.037.912.3, tfna lock drive.Lot number: 34p3035.Lot quantity: 200.Production order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended.Lot number: 17p1870.Lot quantity: 1,000.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from smalley dated oct 18, 2019 were reviewed and determined to be conforming.Part number: 04.037.942.2, lock prong, 130 degree tfna.Lot number: 29p5192.Lot quantity: 110.Two pieces were scrapped in cell at op #80, final inspection, for tool marks in surface finish.Production order traveler met all inspection acceptance criteria apart from the two pieces noted.Part number: 21127, timo agri 16.00.Lot number: 17p7240.Lot quantity: 1,005 lbs.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by perryman company dated aug 23, 2019 was reviewed and determined to be conforming.Lot summary report dated oct 07, 2019 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Device history review: aug 12, 2020: dhr reviewed.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.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent a hardware removal due to the proximal femoral nailing system (tfna) nail and the helical blade became disconnected when the helical blade cut through the femoral head.The internal locking mechanism which holds the helical blade was either not correctly deployed during surgery or there was a failure of this component as the tfna nail and helical blade were no longer in contact.The patient status and the procedure outcome are unknown.Concomitant device reported: unknown locking screw (part# unknown, lot# unknown, quantity# unknown).This complaint involves two (2) devices.This report is for (1) 11mm/130 deg ti cann tfna 380mm/right - sterile this is report 1 of 1 (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
Concomitant devices reported: locking screw (part# unknown, lot# unknown, quantity# unknown); tfna fenestrated helical blade 90mm - sterile (part # 04.038.390s, lot # 13l5990, quantity 1).

• Brand Name: 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - 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: 10442148
• Report Number: 2939274-2020-03740
• Device Sequence Number: 3974920
• Product Code: HSB
• UDI-Device Identifier: 10886982096661
• UDI-Public: (01)10886982096661
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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 Model Number: 04.037.158S
• Device Catalogue Number: 04.037.158S
• Device Lot Number: 36P1023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/18/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FENESTRATED HELICAL BLADE 90MM - STERILE; TFNA FENESTRATED HELICAL BLADE 90MM - STERILE; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR