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

Catalog Number 08.501.001.20S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.Therapy date is unknown.A device history record (dhr) review was performed for part # 08.501.001.20s, lot # l143403: manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 20.Jan.2017, expiry date: 01.Jan.2022: 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 the product that would contribute to this complaint condition.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 appropriately.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during the revision surgery, the locking mechanism of one of the sternal zipfix would not work and the other sternal zipfix from the same lot would not open and lock.Due to patient¿s condition, they decide not to replace it.There was 5-10 minutes surgical delay.Procedure could not be completed successfully.Fragments were removed easily.No depuy synthes implants were used in the primary surgery.The patient got a mediastinitis after primary operation and treated with vacuum-assisted closure (v.A.C) therapy.Concomitant devices reported: sternal zipfix w/needle sterile/20 pack (part # 08.501.001.20s, lot # l143403, quantity 5).This report is for one (1) sternal zipfix with needle sterile/20 pack.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (sternal zipfix with needle sterile/20 pack, part number 08.501.001.20s, lot number l143403): the second device of the two intra operatively used sternal zipfix and 5 original packed zipfix devices are covered in this investigation.Sustaining engineering could not identify any design related root cause of the device failure as described in the customer complaint description.Therefore, this non-manufacturing investigation is closed by sustaining engineering as in-conclusive.A design related root cause is however excluded.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Customer quality investigation of returned devices: two sternal zipfix¿ cable tie w/needle were returned for investigation.It was complained that the locking mechanism of one of the sternal zipfix would not work and the other sternal zipfix from the same lot would not open and lock.The review of the device history records revealed that these implants were manufactured in january 2017 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.The complained parts were forwarded to the responsible product development center for further investigation.Sustaining engineering could not identify any functional or design related issues; the mentioned malfunction could not be reproduced.Design and clinical risk management document was reviewed and found to adequately address the harm of this complaint condition.Visual inspection: some deformation to the device head and cut off section.Dhr no findings.Dimensions: measured at the time of manufacturing with no issues documented.Function test: the mentioned malfunction could not be reproduced.Concomitant parts: the following parts were returned as concomitant devices without an alleged complaint condition.The visual inspection and functional testing of two original packed implants of five returned sternal zipfix¿ cable tie w/needle, showed that they are functional as intended.No additional investigation will be performed.Unfortunately the exact cause of failure cannot be determined; the complaint is determined not to be a result of a detected manufacturer or design related deficiency.The mentioned malfunction could not be reproduced.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: 6640666
• MDR Text Key: 77643047
• Report Number: 3000270450-2017-10195
• 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: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: L143403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/14/2017
• Supplement Dates Manufacturer Received: Not provided; 08/07/2017
• Supplement Dates FDA Received: 06/26/2017; 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1