MAUDE Adverse Event Report: UMKIRCH CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE; TRAY, SURGICAL INSTRUMENT

Catalog Number	03.221.011
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: reportedly, there was no patient involvement.Date of event is unknown.Add'l pro code: fsm.Device is an instrument and is not implanted/explanted.Manufacturing site: (b)(4).Manufacturing date: 27.Feb.2014.No nonconformances were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 clamp of a cerclage passer is not lining up properly.The two points at the top where the cable is supposed to pass through is not lining up.The device may be bent.This was identified in sterile processing.No procedure or patient involvement.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject device (cerclage passer, dividable forceps, large, part number 03.221.011, lot number 8764803.The subject device was returned with the complaint condition stating: the 03.221.011 lot number 8764803 cerclage passer was returned and reported that the points were not lining up and were possibly bent.This complaint condition was likely caused by over three years of consistent use and possible rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, dhr review, and drawing review were performed as part of this investigation.This complaint is confirmed.The 03.221.011 cerclage passer is an instrument routinely used in the cerclage passer system.The device was returned and reported that the points were not lining up and were possibly bent.This condition is confirmed; the distal tips are offset laterally from one another by approximately four millimeters.It is likely that over three years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.The device was manufactured in 2/2014 and is over three years old.The balance of the returned device is in otherwise fairly good condition with only light wear and some mild discoloration near the etchings.Drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.The complaint condition for this device can be replicated.Upon review of the device history record, no ncrs germane to the complaint condition were generated during the production of this device.All measurements have been performed by calipers ca99p.It is likely that over three years of consistent use and possible rough handling during surgery or sterile processing has led 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.

• Brand Name: CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE
• Common Device Name: TRAY, SURGICAL INSTRUMENT
• Manufacturer (Section D): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• MDR Report Key: 6348695
• Report Number: 3003862213-2017-10008
• Device Sequence Number: 635758
• Product Code: LXH
• UDI-Device Identifier: 10886982076731
• UDI-Public: (01)10886982076731(10)8764803
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2017

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: 8764803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2017
• Supplement Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1