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

Model Number	04.037.159S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	05/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.(b)(4).The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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, during removal of proximal femoral nailing system (tfna) long nail and the titanium helical blade, the surgeon removed one (1) distal interlock 5.0mm locking screw and put extraction instrument on the helical blade they then connected the extraction bolt to the proximal instrumented end of the tfna removed the helical blade.They extracted the broken proximal end then proceeded to attempt to remove the distal broken portion of the tfna nail with an extraction hook with no success for 2-3 hours.Then moved to the distal femur to make an opening hole distal to the nail so they can drive out the nail from the distal (retrograde) end.They proceeded in driving the nail until the instrumented proximal portion of the nail was exposed outside of the soft tissue.They put the extraction hook back into the nail and pulled it completely out.It is unknown there was a surgical delay.The procedure was successfully completed.The patient outcome was good.This (b)(4) captures the intraoperative event that during removal there was an additional intervention that was required to remove nail while, this (b)(4) captures the ops-operative event that the broken proximal femoral nailing system (tfna) long nail and the titanium helical blade were removed due to delayed healing and non-union.This complaint involves two (2) devices.This report is for one (1) 11mm/130 deg ti cann tfna 380mm/left - sterile.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: h3, h4, h6 investigation summary visual inspection: the 11mm/130 deg ti cann tfna 380mm/left - sterile (p/n: 04.037.159s, lot #: h869296) was returned and received at us cq.Upon visual inspection, it was observed that the device was broken through the walls of the helical blade opening of the nail.The internal threads of the broken nail at the proximal end were stripped.A drill mark was noted to the device.There were scratches on the device which have no impact on the device functionality.Device failure/defect identified? yes functional testing: functional testing of the received device was not performed due to the received condition of the device.Can the complaint be replicated with the returned devices? no dimensional inspection: the outer diameter of the device was measured to be 15.65 mm.This is within the specification of 15.66 +/-0.1 mm as per the drawing.Dimensional inspection of the internal threads was not performed due to post manufacturing damage.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed -ti canulated trochanteric fixation nail complaint confirmed? yes the stripped internal threads of the tfna might have contributed to the reported device interaction condition.Investigation conclusion the complaint condition was confirmed for the 11mm/130 deg ti cann tfna 380mm/left - sterile (p/n: 04.037.159s, lot #: h869296).There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Pie-1445926; pia-1451581 was launched previous to this complaint to investigate tfna nail breakage and associated drill marks/damage at the head element hole/blade aperture.Please see pie-1445926 for further information.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history part number: 04.037.159s, 11mm/130 deg ti cann tfna 380mm/left- sterile lot number: h869296 (sterile) manufacturing location: monument manufacturing date: 11-apr-2019 expiration date: 28-feb-2029 lot quantity: 6 work order traveler met all inspection acceptance criteria.Inspection sheet, in-process 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 16195 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: 04.037.942.2, lock prong, 130 degree tfna lot number: 3l69966 lot quantity: 96 purchased finished goods traveler met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended lot number: h761704 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 20-nov-2018 were reviewed and determined to be conforming.Part number: 04.037.912.3, tfna lock drive lot number: h850016 lot quantity: 150 work order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part number: 21127, timoagri16.00 lot number: h846839 lot quantity: 2,906 lbs.Certificate of analysis supplied by metalwork inc.Dated (b)(6) 2019 was reviewed and determined to be conforming.Lot summary report dated (b)(6) 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.H11 corrected data d11 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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Brand Name: 11MM/130 DEG TI CANN TFNA 380MM/LEFT - 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: 10067264
• Report Number: 2939274-2020-02382
• Device Sequence Number: 16313155
• Product Code: HSB
• UDI-Device Identifier: 10886982096678
• UDI-Public: (01)10886982096678
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2020

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: 04.037.159S
• Device Catalogue Number: 04.037.159S
• Device Lot Number: H869296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 06/15/2020; 07/01/2020
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 07/01/2020; 07/02/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXTRACTION HOOK - STERILE FOR TI CANNULATED NAILS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR