MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.037.163S

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).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.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 Description

It was reported that on (b)(6) 2022, the surgeon removed a broken long trochanteric fixation nail-advanced (tfna) nail (11mm x 420mm).The procedure was successfully completed.The patient outcome is unknown.This report is for one (1) 11mm/130 deg ti cann tfna 420mm/left - sterile.This is report 1 of 1 for complaint (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h4 device history: manufacturing location: monument.Manufacturing date: 14-nov-2019.Expiration date: 30-sep-2029.Part number: 04.037.163s, 11mm/130 deg ti cann tfna 420mm / left ¿ sterile.Lot number: 24p6389 (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 16859 supplied by ees (albuquerque) 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: 22p0067.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: 17p1883.Lot quantity: 1000.Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certification and certificate of conformance and quality history card supplied by smalley dated 18-oct-2019 were reviewed and determined to be conforming.Part number: 04.037.942.2, lock prong, 130 degree, tfna.Lot number: 19p7495.Lot quantity: 55.One piece was scrapped at 20, edm prong for missing feature.One piece was scrapped in cell at op 40, bead blast, after being dropped.Production order traveler met all inspection acceptance criteria apart for the two pieces noted.Note: initial lot quantity was 56, release quantity was 55, after the two scrapped parts.Inspection sheet, final inspection, met all inspection acceptance criteria.Part number: 21127, timoagri16.00.Lot number: 14l4640.Lot quantity: 1,007 lbs.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by perryman company, dated 12-jul-2019 was reviewed and determined to be conforming.Lot summary report dated 08-aug-2019 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.

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.H10 additional narrative: investigation summary =the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the tfna nail body of the 11/130 deg ti cann tfna 420/left - sile has broken, the broken fragment was returned.No other problems were reported.A dimensional inspection was not performed for the 11/130 deg ti cann tfna 420/left - sile due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 11/130 deg ti cann tfna 420/left - sile would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: 11MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14652188
• MDR Text Key: 294870617
• Report Number: 2939274-2022-02175
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096715
• UDI-Public: (01)10886982096715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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
• Device Operator: Health Professional
• Device Model Number: 04.037.163S
• Device Catalogue Number: 04.037.163S
• Device Lot Number: 24P6389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 07/12/2022; 07/21/2022
• Supplement Dates FDA Received: 07/12/2022; 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male