MAUDE Adverse Event Report: SYNTHES GMBH STERNAL ZIPFIX NEEDLE STERILE -5PK; CERCLAGE, FIXATION

Model Number	08.501.001.05S
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 or Problem Description
Device report from synthes reports an event in india as follows: it was reported that sternal bands loosen after deployment this complaint involves one (1) device sternal zipfix needle sterile -5pk.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: part#: 08.501.001.05s, lot#: 63p3735, manufacturing site: bettlach, release to warehouse date: 15 january 2021, expiry date: 01 october 2025.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the sternal zipfix needle sterile -5pk had no signs of issue or defect.Only one (1) zip was returned from the pack of five(5).The returned device was unused and with the needle still attached.A dimensional inspection was performed for the sternal zipfix needle sterile -5pk and met specifications.A functional test was performed, the needle was cut, the strap was passed through the head of the cable tie, however it would not lock, the device remained loose and was not tight at all.The complaint condition was able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the sternal zipfix needle sterile -5pk would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.D4: lot and expiration date.

• Brand Name: STERNAL ZIPFIX NEEDLE STERILE -5PK
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14626266
• Report Number: 8030965-2022-03749
• Device Sequence Number: 11909240
• Product Code: JDQ
• UDI-Device Identifier: 20887587025985
• UDI-Public: (01)20887587025985
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K110789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2024
• Device Model Number: 08.501.001.05S
• Device Catalogue Number: 08.501.001.05S
• Device Lot Number: 6L19785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown