MAUDE Adverse Event Report: SYNTHES BETTLACH 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 Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Udi: (b)(4).Part number provided (08.501.001.20s) is for a 20 pack of sternal needles; the issue occurred with only 1 device out of the pack.Implant and explant dates: due to intra-operative issues, device was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter phone number: (b)(6).Manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: august 17, 2016.Expiry date: august 01, 2021.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 (b)(4) reports an event in the (b)(6) as follows: it was reported one (1) zipfix sternal needle did not close during an initial procedure.No fragments were generated.The procedure was successfully completed with no delay and no harm to the patient.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and a pd & investigation summary was performed.The investigation of the complaint articles has shown that: the manufacturing documents were reviewed and no complaint related issues were found, this lot of (b)(4) implants ((b)(4)) was manufactured in august 2016.All devices are shipped and we are not aware of any other complaint for this article- and lot number.This speaks against a manufacturing related issue as these devices are manufactured with injection moulding and the first and the last piece of this lot did pass a tensile test of the locking feature as required.The following could be determined by product development on the returned device: no deformations were found on the returned device, which would indicate a root cause of the device failure as described in the complaint.The device was cut at the reduced cross sectional area behind the device needle.This should not be done, as per the technique guide, since this could have an impact on the locking performance of the device by deforming the looking feature within the device head.The clinical reprocessing cycle (washing and sterilization) performed as per the process to return a device to the manufacturer, may have altered the position of the looking feature from its failure position.Therefore, no evidence is found on what may have impacted the device, so that the device intra operatively failed to look.Sustaining engineering cannot identify a specific root cause which would explain the device failure.A design related root cause is excluded.Therefore, this non-manufacturing investigation is closed by sustaining engineering as in-conclusive.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 BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6072445
• MDR Text Key: 58939103
• Report Number: 9612488-2016-10443
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

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 Expiration Date: 08/01/2021
• Device Catalogue Number: 08.501.001.20S
• Device Lot Number: L053135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1