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

Model Number 08.501.001.20S

Device Problem Mechanical Problem (1384)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 09/20/2021

Event Type  Injury  

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: l765033, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: 12 march 2018, expiration date: 01 february 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 Description

Device report from synthes reports an event in united kingdom 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 2 of 2 for complaint (b)(4).

• Brand Name: STERNAL ZIPFIX NEEDLE STERILE-20PK
• Type of Device: 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: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12657775
• MDR Text Key: 277180543
• Report Number: 8030965-2021-08786
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 20887587025992
• UDI-Public: 20887587025992
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: 08.501.001.20S
• Device Catalogue Number: 08.501.001.20S
• Device Lot Number: L765033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: STERNAL ZIPFIX NEEDLE STERILE-20PK
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 107