MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 9MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.004.352S
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	11/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is for a tibial nail.Patient information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 the surgeon was unable to remove the connecting screw from the tibial nail with use of the insertion handle.The entire nail had to be removed from the patient and a new nail inserted with another instrument set.There was a surgical delay of 15 minutes.The im (intramedullary) rod - tibial fracture procedure was completed successfully.Concomitant device reported: insertion handle ((b)(4), lot # 1485664, quantity of 1).This complaint involves two devices.This report is for a tibial nail.(b)(4).
Additional Manufacturer Narrative
The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental 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.
Additional Manufacturer Narrative
A device history record (dhr) review was performed on subject device: manufacturing location: monument, manufacturing date: 26-nov-2014, expiration date: 31-oct-2023: part #: 04.004.352s, lot#: 7849728 (sterile) ¿ 9mm ti cannulated tibial nail-ex/360mm- sterile.Quantity 6.: inspection sheet for in-process acceptance 4004ipa231 rev: h and final inspection 4004fi331 rev: f meet specification.Component parts reviewed: part 21012 bp80 lot: 7782400 reviewed.Raw material received from nf & m international.Certificate of report for titanium meet specification.Raw material receiving/putaway checklist meets requirement.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.Sterility documentation was reviewed and determined to be conforming.¿.A product investigation was performed.The returned tibial nail (part 04.004.352s, lot 7849728, mfg 26-nov-2014) was inspected at customer quality and the complaint was confirmed.Upon visual inspection, it was noted that the tibial nail was bent at the notch where connection to the insertion handle would occur.Whether this complaint could be replicated is not applicable because the device was returned damaged.Tabulated drawings were reviewed and no design issues were identified.Material and relevant testing occurred at the time of manufacture and confirmed to have no issues through the dhr review.While no definitive root cause could be determined it is possible that the device encountered unintended forces (such as being dropped, struck off axis or damaged during sterile processing).During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition, based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not 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.
Additional Manufacturer Narrative
Initially, insertion handle (03.010.045, lot # 1485664, quantity of 1) was reported as a concomitant device but after evaluation, it is no longer and is now an impacted product.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: 9MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7133546
• Report Number: 2939274-2017-50371
• Device Sequence Number: 1423375
• Product Code: JDS
• UDI-Device Identifier: 10886982083951
• UDI-Public: (01)10886982083951(17)231031(10)7849728
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/20/2018

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 Expiration Date: 10/31/2023
• Device Model Number: 04.004.352S
• Device Catalogue Number: 04.004.352S
• Device Lot Number: 7849728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 01/19/2018; 02/20/2018; 02/22/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 01/26/2018; 02/21/2018; 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1