MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12/125 DEG TI CANN TFNA 170 - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.212S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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 or Problem Description
It was reported that on an unknown date, the proximal femoral nailing system (tfna) nail was broken, tfna fenestrated screw was deformed and aiming arm was stripped when received as a blind unit.Patient and procedure involvement are unknown.This report is for one (1) 12/125 deg ti cann tfna 170 - sterile.This is report 1 of 2 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary; visual inspection: 12/125 deg ti cann tfna 170 - sterile (p/n: 04.037.212s, lot #: 12l5265) was returned and received at us cq.Upon visual inspection, the complaint device was broken at the helical blade slot and broken piece was returned.Additionally, scratches and discoloration were observed on the device.No other issues were observed with the returned device.Device failure/defect identified? yes.Complaint confirmed? yes.Investigation conclusion: the complaint could be confirmed for the returned device.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied on the device.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 history lot: manufacturing location: monument; manufacturing date: 24-jul-2019; expiration date: 30-jun-2029; part number: 04.037.212s, 12mm/125 deg ti cann tfna 170mm - sterile; lot number: 12l5265 (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) lppf was reviewed and determined to be conforming.Packaging bom was reviewed and found 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: 04.037.912.2, lock prong, 125 degree, tfna; lot number: 4l03575.Production order traveler met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended; lot number: h795853.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns062851 rev b met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from smalley dated 19-feb-2019 were reviewed and determined to be conforming.Part number: 04.037.912.3, tfna lock drive; lot number: 3l44136.Production order traveler met all inspection acceptance criteria.Inspection sheet, ns062925 rev e met all inspection acceptance criteria.Part number: 21127, timoagri16.00, bp80; lot number: 3l28792.Inspection instruction met all inspection acceptance criteria.Certificate of analysis supplied by metalwerks inc.Dated 09-apr-2019 was reviewed and determined to be conforming.Lot summary report dated 17-may-2019 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review: 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.

• Brand Name: 12/125 DEG TI CANN TFNA 170 - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12318098
• Report Number: 2939274-2021-04638
• Device Sequence Number: 4136715
• Product Code: HSB
• UDI-Device Identifier: 10886982097026
• UDI-Public: 10886982097026
• Combination Product (Y/N): N
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.212S
• Device Catalogue Number: 04.037.212S
• Device Lot Number: 12L5265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/03/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 130 DEG AIMING ARM.; TFNA FENESTRATED SCREW 100MM.; 130 DEG AIMING ARM; TFNA FENESTRATED SCREW 100MM