MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX; GUIDE

Catalog Number	03.008.009
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device is an instrument and is not implanted/explanted.Dhr review was completed for part no.: 03.008.009, lot no.: 1913419: manufacturing location: (b)(4), release to warehouse date: 09.Jul.2008: 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.Customer quality conducted an investigation of the returned device.The returned aiming arm was found to have evidence of impact to the locking hole.Additional areas of the device also show evidence of impact marks.The aiming arm device is etched with ¿do not strike this instrument¿ the sleeve was unable to fully pass through the locking hole due to the damage.The sleeve has gouge marks which evidence attempts to force the sleeve through the damaged locking hole.The complaint is considered confirmed and was able to be replicated.The relevant drawings were reviewed during investigation.Further investigation including dimensional inspection and material and hardness reviews are not applicable, as the issue was determined to be related to post manufacturing impact to the aiming arm, which is not intended to be impacted.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.Based on the investigation findings, it has been determined that no corrective and/or preventive 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.
Event or Problem Description
It was reported that the patient underwent a hindfoot fusion surgery on (b)(6) 2018.The surgeon was using a synthes hindfoot nail.During the surgery, the drill bit sleeve turned out to be stuck in the targeting device while drilling for the locking screws.Since the surgeon exerted some force, the stuck sleeve was removed and the surgery proceeded as scheduled.It was also reported that there was a surgical delay of 10 minutes.The patient outcome was not reported.There is no other information available at this time.During manufacturer¿s investigation of the returned device it was identified that the sleeve was unable to fully pass through the locking hole due to the damage.This condition was re-evaluated and determined to be reportable on (b)(6) 2018.Concomitant device/s reported: unknown locking screw (part # unknown, lot # unknown, qty unknown).This report is for one (1) aiming arm for ti cann hindfoot arthrodesis nail-ex.This is report 1 of 1 for complaint (b)(4).

• Brand Name: AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7508716
• Report Number: 2939274-2018-52154
• Device Sequence Number: 1164502
• Product Code: FZX
• UDI-Device Identifier: 10886982066886
• UDI-Public: (01)10886982066886
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2018

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 Catalogue Number: 03.008.009
• Device Lot Number: 1913419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Initial Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR