MAUDE Adverse Event Report: SYNTHES GMBH EXTRACT-BOLT F/SCR Ø6 6.5+7; EXTRACTOR

Catalog Number	309.069
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent an unknown surgery.During the surgery, the surgeon used the hollow reamer for removing a screw.While the surgeon removing the screw, a part of the hollow reamer broke.The surgery was completed successfully with no surgical delay.During device return visual inspection two (2) additional devices were found to be broken.
Additional Manufacturer Narrative
Product complaint # (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: investigation summary 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 sample revealed thatextract-bolt f/scr ø6 6.5+7 was broken from the tip.Fragments were returned.No other issues were identified.A dimensional inspection for the extract-bolt f/scr ø6 6.5+7 was not 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.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the extract-bolt f/scr ø6 6.5+7 would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.There is no indication that a design or manufacturing issue has caused the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Dimensional inspection: n/a device history part:309.069 lot no:9167705 manufacturing date:01 jun 2015 manufacturing site: werk bettlach.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXTRACT-BOLT F/SCR Ø6 6.5+7
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23905106
• Report Number: 8030965-2025-13018
• Device Sequence Number: 9932315
• Product Code: HWB
• UDI-Device Identifier: 10886982185594
• UDI-Public: (01)10886982185594(10)9167705
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 309.069
• Device Lot Number: 9167705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown