MAUDE Adverse Event Report: SYNTHES GMBH APPLIC-INSTR F/STERNAL ZIPFIX; CERCLAGE, FIXATION

Catalog Number 03.501.080

Device Problem Device Slipped (1584)

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

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j sales representative.A device history record (dhr) review was conducted visual inspection: the applic-instr f/sternal zipfix was received at jrz pal for investigation.The visual inspection of the received device indicated that on of the screws threaded portion was broken and the broken portion is embedded on the counter screw inside the threaded hole.This caused the screw to fell apart from the device.No other issues were identified with the device.Dimensional inspection: complaint relevant dimensional analysis cannot be performed due to post manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Investigation conclusion: the overall complaint was confirmed for the received device as a component in the applic-instr f/sternal zipfix.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 lot - 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 (b)(6) as follows: it was reported that on (b)(6) 2021, during the cleaning process it was noticed that a screw of the instrument was loosen and that instrument cannot be used anymore.No surgery impact and no patient impact.This report is for one (1) applic-instr f/sternal zipfix.This is report 1 of 1 for complaint (b)(4).

• Brand Name: APPLIC-INSTR F/STERNAL ZIPFIX
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13317016
• MDR Text Key: 284374296
• Report Number: 8030965-2022-00493
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07611819418424
• UDI-Public: (01)07611819418424
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.501.080
• Device Lot Number: 7521227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1