MAUDE Adverse Event Report: SYNTHES GMBH EXTRACTION SCREW/M8 FOR SUPRAPATELLAR; EXTRACTOR

Model Number 03.010.446

Device Problem Material Integrity Problem (2978)

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: b3: only event year is known.E3: reporter is a j&j employee.H3, h4, h6: part: 03.010.446 lot no: f-12437 release to warehouse date:13 jan, 2012 manufacturing site: werk selzach supplier: sphinx werkzeuge ag a manufacturing record evaluation was performed for the finished article lot and no non-conformance's were identified.The product was returned to depuy synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the extraction screw/m8 for suprapatellar was found to be stripped from the threaded tip.A dimensional inspection for the extraction screw/m8 for suprapatellar was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the extraction screw/m8 for suprapatellar 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 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

It was reported that on unknown date, while inventorying sets it was noticed that some instruments were affected.There was no patient consequences.This report involves one (1) extraction screw/m8 for suprapatellar.This is report 4 of 4 for (b)(4).

• Brand Name: EXTRACTION SCREW/M8 FOR SUPRAPATELLAR
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17192901
• MDR Text Key: 318020527
• Report Number: 8030965-2023-07995
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982068880
• UDI-Public: 10886982068880
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,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: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.446
• Device Catalogue Number: 03.010.446
• Device Lot Number: F-12437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: EXTRACTION SCREW; REAMING ROD PUSH ROD WITH BALL HANDLE; SDDRIVE SCREWDRIVER SHAFT T8 105MM; T-HANDLE WITH QUICK COUPLING