MAUDE Adverse Event Report: SYNTHES GMBH 2.0 VOLT(TM) CRTX/LCKNG DRILL GUIDE FOR 1.5MM DRILL BITS; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.420.156
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional narrative: h3, h6: part: 03.420.156 synthes lot: j017967 supplier lot: 79413811-j017967 supplier: (b)(4).Release to warehouse date: 29 january 2025 no nonconformance reports (ncrs) generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the device broken from one of the lateral drill guides.The broken fragment was not returned for evaluation.The device arrived without packaging, therefore, the allegation upon receipt cannot be confirmed.Once the product leaves j&j medtech orthopedics control, it is unknown what environment conditions the packaged products are exposed to during that time.Therefore the suspected cause is traced to transport/storage outside of j&j medtech orthopaedics' control.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the 2.0 volt(tm) crtx/lckng drl gd f/1.5 db would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The drawings reflecting the current and manufactured revisions were reviewed.
Event or Problem Description
It was reported that the hospital purchased a new volt mini frag and found that item 2.0 volt crtx/lckng drill guide for 1.5mm drill bits was broken in the packaging.There were no patient consequences.

• Brand Name: 2.0 VOLT(TM) CRTX/LCKNG DRILL GUIDE FOR 1.5MM DRILL BITS
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22089608
• Report Number: 8030965-2025-05233
• Device Sequence Number: 20566800
• Product Code: FZX
• UDI-Device Identifier: 10886982336248
• UDI-Public: (01)10886982336248(10)J017967
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: 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: 03.420.156
• Device Lot Number: J017967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown