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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The 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 device history lot: part: 08.501.001.20s, lot: l892090, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: 27 june 2018, expiration date: 01 june 2023.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 (b)(6) as follows: it was reported that on (b)(6) 2021, that one (1) of the cables had the needle attached in the wrong direction, this was not user error.It was discovered when attempting to insert the cable into the locking mechanism.While attempting to close the other cable, it tightened fine but when attempting to use the tool to trim the excess it shattered/snapped and left an ineffective closure.All of the initial ties were removed and replaced which caused some minor patient bleeding/ local trauma.There was a twenty (20) minute surgical delay.There were no consequences to the patient.This complaint involves two (2) devices.This report is for one (1) sternal zipfix needle sterile-20pk.This is report 1 of 2 for complaint (b)(4).

• Brand Name: STERNAL ZIPFIX NEEDLE STERILE-20PK
• Common Device Name: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12657759
• Report Number: 8030965-2021-08785
• Device Sequence Number: 4232739
• Product Code: JDQ
• UDI-Device Identifier: 20887587025992
• UDI-Public: 20887587025992
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: 08.501.001.20S
• Device Catalogue Number: 08.501.001.20S
• Device Lot Number: L892090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/19/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STERNAL ZIPFIX NEEDLE STERILE-20PK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 107