MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 1.7MM CABLE WITH CRIMP 750MM; CERCLAGE FIXATION

Catalog Number 298.801.01

Device Problem Break (1069)

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

Event Date 10/28/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Implant date is unknown.Explant date is unknown.A review of the device history records has been requested.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 Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during surgery, the cable broke during tensioning.There was no harm to the patient.No surgical delay is reported.All fragments were removed and procedure completed successfully.They used a new cable to complete the surgery.Concomitant reported part: 1x unknown tension instrument.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A device history record (dhr) review was performed for part # 298.801.01, lot # p262156, supplier lot # p262156: release to warehouse date: 17 dec 2016, supplier: (b)(4): no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was performed.It was reported that during surgery, the cable broke during tensioning.This complaint is confirmed.The cable was received at customer quality (cq) in two pieces.The two ends created by the break are also frayed.Whether this complaint can be replicated at (cq) is not applicable for this complaint condition.No new malfunctions were identified as a result of the investigation.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Cable with crimp assembly drawing was reviewed during this investigation.No product design issues or discrepancies were observed.The diameter of the returned cable near location of breakage was measured at cq and is within specification.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Corrected data: brand name, catalog number, udi number.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Device returned to manufacturer.Physical manufacturer.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: 1.7MM CABLE WITH CRIMP 750MM
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7077120
• MDR Text Key: 94202081
• Report Number: 8030965-2017-50249
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07611819721272
• UDI-Public: (01)07611819721272(17)EXPIRATIONDATEUNKNOWN(10)P262156
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K992616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 298.801.01
• Device Lot Number: P262156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2017
• Initial Date FDA Received: 12/01/2017
• Supplement Dates Manufacturer Received: 01/19/2018
• Supplement Dates FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1