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

Catalog Number 08.501.001.05S

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2023

Event Type  malfunction  

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: h3, h4, h6: 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 the three (3) of the pack of five (5) zip fix units were found with the needle end cut and the shaft bent, indicating that the device had been used.Additionally, one (1) of the bent zip fix units was found broken bellow the locking head.The remained two (2) zip fix units were returned with no cosmetic defects.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was conducted following the process established in sternal zipfix® system surgical technique.The two units that returned with no defects had the needle cut off, avoiding to cut at the notch.Then the cut end was aligned with the smooth surface facing up and it was passed through the locking head.The implant was tightened successfully.The same process was performed with the rest of the bent implants and no defects were observed, the devices were able to tightened as intended.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.Device history review (dhr): a manufacturing record evaluation was performed for the finished device, product code: 08.501.001.05s, lot number: 829p113, it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 14/07/2022, manufacturing site: jabil bettlach.Expiry date: 01/06/2027.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 india as follows: it was reported that on (b)(6) 2023, the sternal zipfix malfunctioned during surgery.There was no surgical delay in relation to the event, and no other medical interventions were required.Upon examination of the returned parts on (b)(6) 2023, it was determined that one of the zipfix units was broken below the locking head.This report involves one sternal zipfix with needle sterile / 5 pack.This is report 1 of 1 for (b)(4).

• Brand Name: STERNAL ZIPFIX NEEDLE STERILE -5PK
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18072851
• MDR Text Key: 327395573
• Report Number: 8030965-2023-13930
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 20887587025985
• UDI-Public: (01)20887587025985
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.501.001.05S
• Device Lot Number: 829P113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1