MAUDE Adverse Event Report: SYNTHES HAGENDORF INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX; GUIDE

Catalog Number	03.008.007
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records review was conducted.The report indicates that the: part # 03.008.007; lot # 1541592, manufacturing location: (b)(4), manufacturing date: 03.Oct.2006.No 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.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 connection between the aiming arm and insertion handle seemed to be loose, which resulted in the drill guides not projecting the drill through the nail properly during a procedure on (b)(6) 2017.This delayed the case (3-5) minutes.No fragments were created by the issue, so no fragments were left in the patient.There was no need for increased x-ray during the procedure due to the issue.The treatment was successfully completed with no further issue.There are two devices involved in this complaint.Reported concomitant parts: unknown drill guide (part # unknown, lot # unknown, qty.1).Unknown intramedullary nail: part # unknown, lot # unknown, qty.1).This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Device returned to manufacturer.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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
Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (insertion handle f/hindfoot arthrodesis nail-ex, part number 03.008.007, lot number 1541592).The subject device was returned with the complaint condition stating: it was reported that the connection between the aiming arm and insertion handle seemed to be loose, which resulted in the drill guides not projecting the drill through the nail properly during a procedure on (b)(6) 2017.This delayed the case (3-5) minutes.No fragments were created by the issue.Following device was returned for cq investigation; aiming arm for ti cann hindfoot arthrodesis nail-exp/n 03.008.009, lot# 1924978 insertion handle f/hindfoot arthrodesis nail-ex 03.008.007, lot# 1541592 customer quality (cq) engineering investigation: this complaint was not able to be confirmed at cq.Both the devices assembled together, were able to be locked at different settings, exhibited desired normal amount of resistance to stay in the chosen during locking positions.The complaint condition cannot be replicated as there are multiple concomitant devices, such as drill bit guide, drill bit and nail involved in the complaint condition which were not returned with the complaint.No new malfunctions were identified as a result of the investigation.The returned devices are used in hindfoot arthrodesis nail procedures for nail alignment and installation purpose.A visual inspection under 5x magnification, dimensional inspection of feature(s) related to this complaint, device history record (dhr) review, functional test and drawing review were performed as part of this investigation.Visual inspection: both the devices assembled together, were able to be locked at different settings and exhibited desired normal amount of resistance to stay in the chosen locked positions.Aiming arm and the insertion handle do not have damage at or near the device features that facilitate in assembly and locking of the both devices.Both devices show some wear and minimal scratch marks on the surfaces.The returned parts were determined to be suitable for the intended use when employed and maintained as recommended.Drawing review: insertion handle for hindfoot arthrodesis nail drawings were reviewed.The od of the distal tip measured at 11.04mm (spec: 11 mm +/- 0.2).Aiming arm for hindfoot arthrodesis nail drawings were reviewed.No product design issues or discrepancies were observed.(calipers used: ca301).Unable to determine an exact root cause.The devices assembled per the expectations during investigation at cq location.It was inferred that upon locking the device with the threaded alignment pin, as instructed in the synthes technique guide, the device should be firmly locked in it¿s selected position.There are multiple concomitant devices, such as drill bit guide, drill bit and nail involved in the complaint condition which were not returned with the complaint which could have also contributed to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6679167
• Report Number: 3003875359-2017-10314
• Device Sequence Number: 1970716
• Product Code: FZX
• UDI-Device Identifier: 10886982066855
• UDI-Public: (01)10886982066855(10)1541592
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2017

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: 03.008.007
• Device Lot Number: 1541592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 07/07/2017; 07/20/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 07/12/2017; 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR