MAUDE Adverse Event Report: SYNTHES GMBH STERNAL ZIPFIX NEEDLE STERILE-20PK; CERCLAGE, FIXATION

Model Number	08.501.001.20S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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: device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter state: (b)(4).Initial reporter occupation: reporter is a j&j sales representative.Device evaluated by mfr: 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
(b)(4).This complaint involves three (3) devices.This report is for one (1) sternal zipfix needle sterile-20pk.This is report 1 of 3 for complaint.
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: b5 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 depuy synthes reports an event in canada as follows: it was reported that intraoperatively on an unknown date, while tightening to close the sternum (thorax) the 2 zipfixes broke and third zipfix did not close when closing the sternum despite using the tensioner.Problem occurred several times.Surgeon ended up closing with sternal plates and screws to avoid wound opening and the surgical delay was around twenty (20) minutes.The surgery was successfully completed.There was no patient consequence.This report is for one (1) sternal zipfix with needle sterile/20 pack this is report 1 of 3 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.Additional narrative: d4, h4 a manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.Product code: 08.501.001.20s, lot no: 232p949, manufacturing site: jabil bettlach, release to warehouse date: 03/10/2021, expiry date: 31/07/2026.Product was not returned.Based on the information available, it has been determined that no corrective and 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: STERNAL ZIPFIX NEEDLE STERILE-20PK
• 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: 16237086
• Report Number: 8030965-2023-00888
• Device Sequence Number: 6405904
• Product Code: JDQ
• UDI-Device Identifier: 20887587025992
• UDI-Public: (01)20887587025992
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• 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: 07/31/2026
• Device Model Number: 08.501.001.20S
• Device Catalogue Number: 08.501.001.20S
• Device Lot Number: 232P949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 01/05/2023; 02/08/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 01/25/2023; 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2021
• 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-20PK; STERNAL ZIPFIX NEEDLE STERILE-20PK
• Patient Sex: Unknown