MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 440MM/LEFT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.265S
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
Product complaint #: (b)(4).Reporter is a j&j representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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
It was reported that on an unknown date, tfna fenestrated helical blade, ti cannulated tfna nail, and an unknown screw were received broken.There was no procedure and patient involvements are reported.This complaint involves three(3) devices.This report is for (1) 12mm/130 deg ti cann tfna 440mm/left-sterile.This report is 2 of 3 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: the 12/130 deg ti cann tfna 440/left-sterile (p/n: 04.037.265s, lot number: h763038) was received at us cq.Upon visual inspection at cq, it was observed the nail was broken into two pieces around helical blade slot.Rest of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.No other issues were observed with the complaint device.Device failure/defect identified? yes.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint was confirmed.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 for the reported condition could be due to unintended force applied to the complaint 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: 30-oct-2018; expiration date: 30-sep-2028; part number: 04.037.265s, 12mm/130 deg ti cann tfna 440mm/left- sterile; lot number: h763038 (sterile).Work 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 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: component parts were not reviewed as the reported complaint condition of ¿received broken pre-operatively¿ indicates shipping damage.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.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.Corrected data: h3, h6.

• Brand Name: 12MM/130 DEG TI CANN TFNA 440MM/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: 12316144
• Report Number: 2939274-2021-04628
• Device Sequence Number: 11714027
• Product Code: HSB
• UDI-Device Identifier: 10886982097453
• UDI-Public: (01)10886982097453
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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: 04.037.265S
• Device Catalogue Number: 04.037.265S
• Device Lot Number: H763038
• 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: 08/16/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/03/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FENESTRATED HELICAL BLADE 115MM.; UNK - SCREWS: NAIL DISTAL LOCKING.