MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 85MM STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.285S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is not available for reporting.Original implant date is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes sales consultant.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2018, a hardware removal of one trochanteric fixation nail-advanced (tfna) nail and one (1) tfna helical blade was performed.The sales consultant noted that the helical blade did not collapse as it typically functioned.This led to the impinging of the implant into the right hip of the patient, requiring a total hip replacement.It was unknown if there was any surgical delay.Patient and procedure outcomes were unknown.Concomitant devices reported: 10mm/130 deg ti cann tfna340mm/right sterile (part number: 04.037.054s, lot number: h407885, quantity: 1).This report is for one (1) tfna helical blade 85mm sterile.This is report 1 of 1 for complaint (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.Part 04.038.285s, lot h588101: manufacturing location: synthes elmira.Released to warehouse date: march 30, 2018.Expiration date: february 28, 2028.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was completed: the device was received with signs of wear.There are nicks on the sharp distal tip of the helical blade and cuts on the shaft of the helical blade just above the cutting portion of the helical blade.These are all signs of damage that is consistent with a removal surgery.The complaint was not able to be replicated since the helical blade migration occurred within the patient post-operatively.This complaint cannot be confirmed as the allegation is against a postoperative event and there is no evidence on the device that confirms or denies that the event occurred.Medical images were not provided.Therefore, the complaint is not confirmed.Dimensional analysis was completed, and the device is within specifications.The relevant drawing was reviewed.The complaint condition is not confirmed as the helical blade migrated post-operatively within the patient.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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: TFNA HELICAL BLADE 85MM 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: 7715625
• Report Number: 2939274-2018-53062
• Device Sequence Number: 1065706
• Product Code: HSB
• UDI-Device Identifier: 10886982098979
• UDI-Public: (01)10886982098979
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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: 04.038.285S
• Device Catalogue Number: 04.038.285S
• Device Lot Number: H588101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/30/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: UNKNOWN.; THERAPY DATE: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention