MAUDE Adverse Event Report: SYNTHES HAGENDORF SYNFRAME RING CLAMP; MISC ORTHO SURGICAL INSTR

Catalog Number 387.347

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.Date of event/therapy date was reported as (b)(6) 2017.It is unknown if all the devices malfunctioned on the same day or during same procedure.Device is an instrument and is not implanted / explanted.(b)(6).Device history records review was completed for part# 387.347, lot# 3097068.Manufacturing location: (b)(4), manufacturing date: mar 13, 2009.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was 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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the reported clamps were stiff and coming off the ring very easily.The vascular surgeons felt that this is potentially dangerous around vessels.Reportedly, this occurred during use on the patient.However, it is unknown if this occurred during multiple occasions or the exact date it occurred.Patient and surgery outcome were not reported.Synfram ½ holding (part# 387.337, lot# unknown, quantity 3).Synfram holding (part# 387.336, lot# unknown, quantity 3).This report is for one (1) synframe ring clamp.This is report 7 of 8 for (b)(4).

Manufacturer Narrative

Product development investigation was completed.A visual inspection, device history records review and function test was completed as part of this investigation.Upon visual and incoming inspection of the complaint devices, it was noted that on some position the coating is already gone.Furthermore, the articles are showing marks and deformation from usage over the years.During investigation, a functional test was performed.The clamps passed the functional test.The reported devices were assembled according to drawing, and went through 100% functional test before they left the production.This complaint was classified as normal wear and tear, and such instruments must be replaced from time to time.Complained issue could not be replicated and/or confirmed based on the available information.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: SYNFRAME RING CLAMP
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6951385
• MDR Text Key: 90552277
• Report Number: 3003875359-2017-10510
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819141278
• UDI-Public: (01)07611819141278(10)3097068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 387.347
• Device Lot Number: 3097068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1