MAUDE Adverse Event Report: SYNTHES GMBH STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK; CERCLAGE, FIXATION

Catalog Number	08.501.001.05S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from india reports an event as follows: it was reported that during an unknown procedure on (b)(6) 2023, the zipfix in question did not tighten properly.There was no reported adverse patient impact.No further information is available.This report is for a sternal zipfix with needle sterile / 5 pack.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: initial reporter is a synthes employee.H3, h6: 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.
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, h4, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
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: a manufacturing record evaluation was performed for the finished device.Part: 08.501.001.05s, lot: 63p3735.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 15 january 2021, manufacturing site: jabil bettlach, expiry date: 01 october 2025.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 sternal zipfix needle sterile -5pk revealed that just 2 were returned for investigation , both were found with the needle end cut and the shaft bent, indicating that the device had been used.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test performed on the locking of the tabs onto the teeth determined all the zipfix units to perform as intended.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the sternal zipfix cable tie w/needle peek 5 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.Drawing/specifications reviewed current and manufactured revisions were reviewed.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 / 5 PACK
• 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 CO 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18300871
• Report Number: 8030965-2023-15538
• Device Sequence Number: 3177066
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 10/01/2025
• Device Catalogue Number: 08.501.001.05S
• Device Lot Number: 63P3735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 12/19/2023; 02/13/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/11/2024; 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STERNAL ZIPFIX NEEDLE STERILE -5PK; STERNAL ZIPFIX NEEDLE STERILE -5PK; STERNAL ZIPFIX NEEDLE STERILE -5PK; STERNAL ZIPFIX NEEDLE STERILE -5PK
• Patient Sex: Unknown