MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW F/TROCHANTERIC FIXATION NAILS; GUIDE

Catalog Number	357.397
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id: (b)(6).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records 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 patient underwent revision on (b)(6) 2018 due to a titanium trochanteric fixation nail (tfn) distal screw missing the nail.Original hardware was implanted on (b)(6) 2018 to treat a reverse oblique hip fracture; it was noted during that procedure there was a two-minute delay.During that procedure, only anterior x-rays were taken; lateral x-rays were not done.X-rays taken on (b)(6) 2018 discovered that the screw had missed the nail; the distal screw was lodged in the patient¿s bone.A possible misalignment of the instrumentation may have caused the distal screw to be misguided and miss the nail.There was no reported issue with the helical blade.The instrumentation that may have contributed to the misalignment, consisted of an insertion handle, aiming arm, connecting screw and cannula.Upon reviewing the x-rays on (b)(6) 2018, it was also noted a small hairline fracture of the femur bone was present at the bottom of the nail and the patient reported pain.Patient underwent revision surgery the same day to remove the short nail along with the helical blade and distal screw that was lodged in the patient¿s bone.Patient was revised to a longer nail, another helical blade and two (2) new distal screw.The patient was revised from a short nail to a long nail to span the hairline fracture.The revision surgery was completed successfully and there was no surgical delay during the revision on (b)(6) 2018.Concomitant device reported: helical blade (part 456.3xx, lot unknown, quantity 1) this is report 2 of 6 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.Additional narrative: device evaluated by mfr, device manufacture date.Part number: 357.397; synthes lot number: 6365450; supplier lot number: n/a; release to warehouse date: july 09, 2010; expiration date: n/a; supplier: isimac machine company.No nonconformance records (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation summary: customer quality investigation: the following investigations were performed: device interaction/ functional: device condition: the returned device was visually examined, and no visual defects were identified.All the devices that constitute the nail implanting construct were not returned, and the nail was not returned; therefore, a full functional inspection to replicate intraoperative conditions was not possible at customer quality.Functional inspection was performed with the available returned devices.Functional inspection performed on the connecting screw with the returned mating devices (insertion handle) showed no issues with mating and alignment.The connection screw was able to slide through the insertion handle cannulation and was observed to be positioned as intended at its thread mating portions with the insertion handle.Furthermore, no issues were noted on the connection end of the screw that connects to the nail.Additionally, no alignment issues were identified with these returned devices (connection screw, aiming arm, insertion handle and protection sleeve) when assembled as a construct and therefore, no functional issues were identified on the returned devices.Complaint condition was not able to be confirmed as no functional issues were noted.Furthermore, replication of given compliant condition was not possible at customer quality.However, further evaluation that includes design drawing review, dhr review including risk document review was performed to identify any potential issues that would have contributed to complaint condition.Dimensional analysis and document/specification review: relevant drawings for the returned device (connection screw drawing) were reviewed (both current revision and from the time of manufacture).With no mating devices returned and no visual defects identified, dimensional analysis was determined to be irrelevant to the given complaint condition.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.No ncrs were generated during production.No definitive root cause was able to be determined with the available returned devices.Conclusion: this complaint was not able to be confirmed and no product design issues or manufacturing discrepancies were identified during 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: CANNULATED CONNECTING SCREW F/TROCHANTERIC FIXATION NAILS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7801368
• Report Number: 2939274-2018-53400
• Device Sequence Number: 1293497
• Product Code: FZX
• UDI-Device Identifier: 10886982196224
• UDI-Public: (01)10886982196224
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

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 Catalogue Number: 357.397
• Device Lot Number: 6365450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 170