MAUDE Adverse Event Report: SYNTHES GMBH EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS; EXTRACTOR

Catalog Number 309.039

Device Problem Material Integrity Problem (2978)

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

Event Date 07/04/2023

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent removal surgery with the extraction bolt.Removal surgery was performed as bone fusion was achieved.During the surgery, there was a defect with the extraction bolt.The screw could not be attached because the threading of the extraction bolt did not engage with the threading of the screw shaft.The surgeon shaved around the shaft to the screw tip and directly removed the screw.There are no pieces in the patient.The surgeon confirmed by x-ray and all plates and screws were removed.There was an extension of surgery time within 30 minutes.During manufacturer's investigation of the returned device it was identified that the inner threads of the device from the distal tip are stripped, the overall device has a worn appearance.This report is for one (1) extraction bolt for 3.5mm & 4.0mm screws.This is report 2 of 2 for complaint (b)(4).

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: e3: reporter is a j&j employee.H3, h6: a product investigation was conducted.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the device found the inner threads from the distal tip stripped, the overall device has a worn appearance.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.The device exhibits damage consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was not performed as it is not applicable to complaint condition.The overall complaint was confirmed as the observed condition of the extraction bolt for 3.5mm & 4.0mm screws would contribute to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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.H3, h4, h6: device history record (dhr) review conducted: part# 309.039.Lot # 2715805.Manufacturing site: werk selzach logistik.Supplier: (b)(4).Release to warehouse date: 03 may 2011.Expiration date: na.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.

• Brand Name: EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS
• 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 17665864
• MDR Text Key: 322449304
• Report Number: 8030965-2023-11064
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819056503
• UDI-Public: (01)07611819056503
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309.039
• Device Lot Number: 2715805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2011
• 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: UNK - SCREWS: TRAUMA