MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CERCL-CABLE W/CRIMP Ø1.7; CERCLAGE FIXATION

Catalog Number 611.105.01S

Device Problems Difficult to Insert (1316); Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.Not implanted or explanted, another device was used.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dice was used for treatment, not diagnosis.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a patient underwent an open reduction internal fixation (orif) for a periprosthetic femoral fracture on (b)(6) 2018.The procedure was performed with locking compression plate (lcp) distal femur plate.During surgery, when the surgeon inserted the cable into the cable tensioner, it didn't come out from the other side of the tensioner.The cable could not be tensioned.After trying to apply the tension, the cable could not be pulled out nor be moved forward.The surgery was finished by cutting the cable and using another soft wire.There was a surgical delay of 30 minutes.The procedure was completed with the patient in stable condition.This report is for two (2) devices.This complaint involves one (1) 1.7mm cocr cable with ti crimp 750mm-sterile.This report is 2 of 2 for (b)(4).

Event Description

Concomitant device: lcp distal femur plate (part unknown, lot unknown, quantity unknown).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device evaluated by mfr, device manufacture date: without a lot number the device history records review could not be completed.Customer quality conducted an investigation of the returned device.Investigation selection: investigation site: cq zuchwil.Selected flow: 2.Device interaction/functional, unable to disassemble.Visual inspection: our investigation has shown that a cable in the cable tensioner is completely jammed.Also, its visible that several cords of the cable are jammed in the gripping mechanism (clamping jaws).Functional test: during our investigation, the cable could also not be removed by trying to turn the knob counterclockwise at the end of the tensioner.Dimensional inspection: because of the jammed cable the complaint relevant dimensions cannot be checked to print specifications anymore.Drawing/specification review: review of the device history records showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Summary: the complaint condition can be confirmed, due to evidence that the cable is jammed in the cable tensioner.Afterwards and without any further details, it is unfortunately not possible to determine the exact cause for this jamming.We only can assume that during the operation an application error may have taken place.Please note our op instructions."turn the fluted knob at the end of the tensioner counterclockwise as far as possible, thus the insertion / removal of the cable is guaranteed".In this regard, alternatively the new cable tensioner 03.221.015 (one-hand operable cable tensioner) can also be used.During the investigation no manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected corrected data: event, concomitant medical products.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: CERCL-CABLE W/CRIMP Ø1.7
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7932240
• MDR Text Key: 122635168
• Report Number: 8030965-2018-56983
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07611819757615
• UDI-Public: (01)07611819757615
• Combination Product (y/n): N
• PMA/PMN Number: K992616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 611.105.01S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Date Manufacturer Received: 11/13/2018
• Patient Sequence Number: 1