MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 170MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.037.142S

Device Problems Break (1069); Migration (4003)

Patient Problems Pain (1994); Non-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: 510k: this report is for an unknown nails: tfna/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j employee.(b)(4).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.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.Investigation summary: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment ((b)(4) litigation records ad 24 mar 2022).On visual inspection of the provided image of the unk - nails: tfna, no observations could be made due to the poor image quality.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for unk - nails: tfna.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.

Event Description

Device report from synthes reports an event in the usa as follows: it was reported that on (b)(6) 2020, patient had a comminuted intertrochanteric hip fracture and was implanted with tfna device.On (b)(6) 2020, patient undergone unnecessary explant and revision surgery.A photograph depicting broken trochanteric nail was provided in the medical record.This complaint involves one (1) device unk - nails: tfna.This is report 1 of 1 for complaint (b)(4).

Event Description

It was further reported that on (b)(6), 2020 patient had undergone revision of tfna due to left intertrochanteric femur fracture with impending non-union and also added event left femoral head, cut-out also/fracture femoral head.Operative reported patient had worsening pain with collapse of intertrochanteric femur fracture in an uncontrolled manner, appeared that lag screw had spun within the nail had fractured.This is report 1 of 3 for (b)(4) and captures patient's first revision surgery.Patients second revision surgery is captured under (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.D2: additional procode: ktt.H4, h6: manufacturing location: (b)(4).Manufacturing date: 25 october 2019.Expiration date: 30 september 2029.Part: 04.037.142s, 11mm/130 deg ti cann tfna 170mm-sterile.Lot: 22p0172 (sterile).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 all components issued met current defined requirements.Sterilization control number (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: 04.037.912.3, tfna lock drive.Lot: 17p8707.Production order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part: 04.037.912.4, wave spring, shim ended.Lot: 10l4209.Production 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 were reviewed and determined to be conforming.Part: 04.037.942.2, lock prong, 130 degree tfna.Lot: 16l0683.Production order traveler met all inspection acceptance criteria.Inspection sheet, final inspection met all inspection acceptance criteria.Part: 21127, timoagri16.00.Lot: 13l9972.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by perryman company was reviewed and determined to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from the received images.On visual inspection of the provided image, a part of the lock prong was observed broken.Migration/backout/pull-out/subsidence condition was not confirmed as x-ray evidence photos were not provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for tfna fem nail ø11 130° l170 timo15.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.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.B5 - number of reports.

• Brand Name: 11MM/130 DEG TI CANN TFNA 170MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14161800
• MDR Text Key: 289665739
• Report Number: 2939274-2022-01398
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819650503
• UDI-Public: (01)07611819650503
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.142S
• Device Lot Number: 22P0172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN.; TFNA SCR L95 TAN.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female