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

Catalog Number 08.501.001.20S

Device Problem Unintended Movement (3026)

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

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier is not available for reporting.Udi (b)(4).Hospital address and telephone not available for reporting.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review was completed.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.Manufacturing location: (b)(4).Supplier: external supplier (b)(4).Manufacturing date: 07.Feb.2017 expiry date: 01.Jan.2022.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 patient was implanted with two (2) sternal zipfix implants on (b)(6) 2017.A few hours later patient was returned to surgery due to a bleeding complication.During the second surgery it was noted that one (1) of the zipfix implants was loose.The zipfix was removed and replaced with cerclage.Surgeon noted the bleeding complication was probably not due to the zipfix implanted earlier.Concomitant devices reported: sternal zipfix with needle (08.501.001.20s, lot l117503, quantity 1) this report is for one (1) sternal zipfix with needle.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Date of event/surgery date, implant date, and explant date updated.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 sweden as follows: it was reported patient was implanted with two (2) sternal zipfix implants on (b)(6) 2017.A few hours later patient was returned to surgery due to a bleeding complication.During the second surgery it was noted that one (1) of the zipfix implants was loose.The zipfix was removed and replaced with cerclage.Surgeon noted the bleeding complication was probably not due to the zipfix implanted earlier.

Manufacturer Narrative

Hospital telephone: (b)(6).Returned devices were forwarded to the manufacturing site for investigation.Two sternal zipfix devices were returned.While the first one had been returned in broken state and represents the actual complaint the second one was tightened by the hospital to check if the complaint could be replicated.The hospital claimed no issue with the second device.Sustaining engineering did not identify any design related root cause which would explain the one device failure as seen in this complaint.Improper alignment during insertion of the toothed end into locking head has led to unilateral deformation in the locking head which in turn caused the stripping of the device.A design related root cause is excluded.This non-manufacturing investigation is closed by sustaining engineering as in-valid.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: STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK
• 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: 6865381
• MDR Text Key: 86288722
• Report Number: 3000270450-2017-10326
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110789
• 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,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 08.501.001.20S
• Device Lot Number: L117503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ZIPFIX (08.501.001.20S, LOT L117503, QTY 1)
• Patient Age: 72 YR
• Patient Weight: 113