MAUDE Adverse Event Report: SYNTHES BETTLACH STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK; CERCLAGE FIXATION

Catalog Number 08.501.001.20S

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 04/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Due to the intra-operative events, the implant was not successfully implanted.As such, implant/explant dates are not applicable.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(6).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.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 on (b)(6) 2017 after cutting the zipfix with the application instrument, the locking head of the implant opened again.The implant was removed.The sales rep tested the zipfix and the locking head seemed to work.The surgery was not prolonged.Instead of five only four zipfix were implanted; however the surgery was successfully completed.No information available about patient condition.Concomitant reported devices: application instrument (part # unknown, lot # unknown, quantity 1).This is report 1 of 1 for complaint (b)(4).

• Brand Name: STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6585955
• MDR Text Key: 75917017
• Report Number: 9612488-2017-10227
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 08.501.001.20S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1