MAUDE Adverse Event Report: SYNTHES SELZACH 1.7MM CABLE WITH CRIMP 750MM-STERILE; CERCLAGE FIXATION

Catalog Number 298.801.01S

Device Problem Break (1069)

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

Event Date 02/08/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional narrative: (b)(6).(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Device history records review was conducted.The report indicates that the: manufacturing location: please note, this dhr review is for sterilization procedure only 298.801.01s / 9588493; manufacturing location: (b)(4); supplier: (b)(4); manufacturing date: 03.Aug.2015; expiry date: 01.Jul.2025.No ncrs were generated during production.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.Non-sterile 404.034 / 8535031; 298.801.01 / p211378; manufacturing location: usa / (b)(4).Dhr for the non-sterile part: dhr review for part #298.801.01, lot #p211378; release to warehouse date: 15-jun-2015; expiration date: na; supplier: rti surgical.No ncrs were generated during production.Review of the device history records showed that there were no issues during the manufacture of this product that would contribute 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.

Event Description

Device report from synthes on an event in (b)(6) as follows: t was reported that during surgery on using the cerclage cables with the mipo gun, three cable frayed and one of them shattered into small pieces breaking off into the patient.They used then the cylinder tensioner and the rest went fine.The surgeon did not overtighten the cables although they failed during tensioning.The surgery was completed with no adverse outcome to the patient or no patient harm.The surgery was prolonged about 10 minutes.No information available about patient condition.There is possibly also an allegation against the mipo gun.The surgeon was confident that all shards were removed.They were of retrievable size and were superficial.This complaint involves 4 parts.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the broken cable was not returned; however two cable tensioners (part 03.221.015, lot p162067) were received and investigated.Functional testing for the tensioners confirmed that both are reading slightly lower than the expected.The measurements confirm that the tensioners do not meet manufacturing tension specifications.However, due to the lower tension readings, it has been determined that the tensioners would not inflict the type of damage to the cables that has been reported in this complaint.Unfortunately we are not able to determine the exact reason for this occurrence, but it is likely that during the operation an application error may have taken place.No product fault could be detected.No manufacturing related issue was identified and/or confirmed.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-STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6382813
• MDR Text Key: 69205250
• Report Number: 3000270450-2017-10075
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 298.801.01S
• Device Lot Number: 9588493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 03/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1