MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 360MM/LEFT-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.257S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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 patient presented with broken titanium cannulated advance proximal femoral nailing system (tfna) and nonunion.The hardware was removed successfully, and all parts were recovered.Patient was revised to a new nail.Original surgery was on (b)(6) 2018.A new nail was implanted.Procedure outcome is unknown.The patient was doing fine.Concomitant devices: tfna fenestrated helical blade (part: 04.038.390, lot: h323579, quantity: 1), distal locking screws (part: unknown, lot: unknown, quantity: 1).This report is for a titanium (ti) cannulated tfna.This is report 1 of 1 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.A device history record (dhr) review was conducted: part number: 04.037.257s, 12mm/130 deg ti cann tfna 360mm/left- sterile, lot number: h524605 (sterile): manufacturing location: monument, manufacturing date: 14-dec-2017, expiration date: 30-nov-2027, lot quantity: (b)(4).Work order traveler 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.Component parts reviewed: 04.037.912.4, wave spring, shim ended, bp55, lot number: h474688, lot quantity: (b)(4).04.037.942.2, lock prong, 130 degree tfna, bp55, lot number: l643434, lot quantity: (b)(4).04.037.912.3, tfna lock drive, bp58, lot number: h511328, lot quantity: (b)(4).21127, timoagri16.00, bp80, lot number: h323700, lot quantity: (b)(4).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.H6: the device was not returned.Photographic images were reviewed by us customer quality investigations.The images depict a broken nail.An oblique break occurred at the head-element hole.No other issues were observed with the nail, or concomitant helical blade and locking screw.The condition of the nail depicted in the images agrees with the complaint description; the complaint was confirmed.Document/specification review: the relevant drawings were reviewed:during the investigation, no product design issues were observed that may have contributed to the complaint condition.Conclusion: the complaint condition was confirmed.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.Risk documentation review found that the complaint is adequately addressed by the risk assessment.A root cause could not be determined as the event conditions were unknown; however, it is likely the device experienced extreme forces while implanted.The complaint condition is adequately addressed by the risk assessment.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 12MM/130 DEG TI CANN TFNA 360MM/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: 8445163
• Report Number: 2939274-2019-57090
• Device Sequence Number: 1795151
• Product Code: HSB
• UDI-Device Identifier: 10886982097378
• UDI-Public: (01)10886982097378
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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: 04.037.257S
• Device Catalogue Number: 04.037.257S
• Device Lot Number: H524605
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 59