MAUDE Adverse Event Report: UMKIRCH CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE; MISC ORTHO SURGICAL INSTR

Catalog Number	03.221.011
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Device is an instrument and is not implanted/explanted.Telephone number unknown.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Manufacturing location: (b)(4).Manufacturing date: 06.May.2011.Nonconformance (ncr) was generated during production.This ncr documented use as is release with all required approvals.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.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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during surgery the wire passers do not meet at the tip.The passing tube cannot be passed through them.To resolve the problem they used a standard wire passer.The surgery was prolonged about 10 minutes.There was no patient harm and the surgery was successfully completed.Concomitant reported part: 1x unknown passing tube.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product investigation was performed.The investigation confirmed that the tips of cerclage-passer are deformed and that they are not flush anymore.Due to these damages the relevant dimensions cannot be verified anymore.Therefore, the manufacturing documents were reviewed and no complaint related issues were found.The device was manufactured in may 2011 and did pass the required function test back then.The visual inspection has shown that the cerclage-passer is in a very used condition, there are discolorations and stress marks all over the instrument, also there are strong marks of hammer blows at both tubes visible.This indicates that this device was often and very intense used during its life span, which speaks against a manufacturing related issue.Based on the provided information we are not able to determine the exact cause of the deformation.A drop to the ground or inappropriate handling, which would explain the hammer marks, are possible causes.In general, we would like to mention the handling technique cable application is stated: precaution: to prevent damage do not apply too much force while inserting the cerclage passer.Deformation of the tubes can result in non-closure of the instrument when connecting the halves.No product related issue could be detected.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: CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• MDR Report Key: 6755384
• Report Number: 3003862213-2017-10018
• Device Sequence Number: 129948
• Product Code: LXH
• UDI-Device Identifier: 07611819880108
• UDI-Public: (01)07611819880108(10)3759698
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2017

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: 03.221.011
• Device Lot Number: 3759698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1