MAUDE Adverse Event Report: SYNTHES BETTLACH STERNAL ZIPFIX WITH NEEDLE STERILE; CERCLAGE FIXATION

Catalog Number 08.501.001.01S

Device Problems Component Missing (2306); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/08/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: although the product issue was discovered on (b)(6) 2016, it is unknown when the device ribbing portion (locking mechanism) was missing from the device.(b)(4).(b)(6).The subject device is not expected to be returned to the synthes manufacturer for evaluation.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(4) reported an event in (b)(6) as follows: it was reported that the locking mechanism of two zipfix implants did not work properly; the ribbing portion of the implant is missing.The issue was detected preoperatively on (b)(6) 2016 and there was no patient involvement.This report is 2 of 2 for (b)(4).

• Brand Name: STERNAL ZIPFIX WITH NEEDLE STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5391654
• MDR Text Key: 36849202
• Report Number: 9612488-2016-10056
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK110789
• 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
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: 08.501.001.01S
• Device Lot Number: 9659492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1