MAUDE Adverse Event Report: UMKIRCH CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number	03.221.010
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: there was no reported patient involvement associated with the complained event.Event date: unknown.Device is an instrument and is not implanted/explanted.(b)(6).The 510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The subject device has been received and is currently undergoing investigation.A device history record review was performed for the reported subject device lot.Manufacturing location: synthes (b)(4).Date of manufacture: feb 15, 2016.The review showed that there were no issues during the manufacture of the product lot that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 reported an event in (b)(6) as follows: it was reported that the tip of the cerclage passer is deformed.There was no reported patient involvement.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
An investigation summary was performed.The investigation of the complaint articles has shown that: the investigation confirmed that the tips from the instrument plier are deformed.The document review for material and production showed that the instrument has been produced in february 2016 and meets specification.Furthermore these instruments underwent a 100% functional inspection before leaving the plant.Without any further details afterwards it is unfortunately not possible to detect the cause for this deforming.In general we would like to indicate within insertion and clothing of the loop instruments exceeding force has to avoid elsewise deformation of the tubes brings forward.Complaint is disposed as confirmed due to evidence that tips are deformed, but it's considered not valid for manufacturing standpoint because there is no evidence of issues manufacturing related.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, SMALL
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• MDR Report Key: 6440223
• Report Number: 3003862213-2017-10010
• Device Sequence Number: 780093
• Product Code: LXH
• UDI-Device Identifier: 10886982076724
• UDI-Public: (01)10886982076724(10)9741279
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2017

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: 03.221.010
• Device Lot Number: 9741279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1