MAUDE Adverse Event Report: SYNTHES GMBH DRIVE SHAFT FOR RIA 2 520MM; REAMER

Catalog Number	03.404.035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
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 j&j medtech, or its employees that the report constitutes an admission that the product, j&j medtech, 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.H11 additional manufacturer narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that the drill head of the ria 2 with a diameter of 22 has suffered a break during use.
Additional 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.H11 additional narrative: added: d4 (lot), h4 corrected: d4 primary udi number.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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.H11 additional narrative: added: b5, b14 (to capture dhr) corrected: h3.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h6 product investigation: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there were no damage or defect with the drive shaft f/ria 2 l520, the internal spline from auger (part number: 03_404_035_07) was examined under magnification and there is no indication of damage/broken condition that can be contribute to inability to connect properly the mating device.Per the ria 2 (reamer irrigator aspirator) surgical technique guide se_828354 rev.Ac page 7: attach drive unit to the end of the drive shaft.Attach the assembled tube assembly with drive shaft to a modified trinkle drill adapter.Select a power drive unit that will deliver 3.5 nm to 6.0 nm of torque and 700 rpm to 900 rpm (standard drill speed) ensure drill setting is selected for the power driver.Precaution: do not use drill with torque greater than 6 nm.Do not use a reduction drive.Do not use power driver designed for reaming.Note: do not turn the power on when the drive shaft is disengaged from the tube assembly.Page 9: attch reamer head.Using the protective sleeve, insert the selected reamer head (determined in step 2) into the distal end of the drive shaft until it is fully seated.Note: the gear of the reamer head needs to be aligned with the spline in the drive shaft to be fully seated.Precaution: reamer heads are extremely sharp.Use the provided protective sleeve to handle the reamer head.A dimensional inspection was performed for the drive shaft f/ria 2 l520 and met specifications.A functional test was not performed due to the mating device was not received to assess the interaction between devices.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the drive shaft f/ria 2 l520 was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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 review (dhr): dhr information was retrieved from (b)(4) was it is the same lot number.Manufacturing location: supplier ¿ (b)(4) / inspected and packaged by: monument.Release to warehouse date: 17-apr-2020 part number: 03.404.035, drive shaft for ria 2 520mm lot number: h887254 (non-sterile) lot quantity: (b)(4).Purchased finished good traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns073689 rev a met all inspection acceptance criteria.Certificate of compliance supplied by (b)(4) dated 27-feb-2020 was reviewed and determined to be conforming.Hardness values certified to meet specified requirements.Related raw material certifications were reviewed and determined to be conforming.Packaging label log (pll) lmd rev aa was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Device history review (dhr): this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information was received and stated that the surgery was completed successfully.No surgical delays.

• Brand Name: DRIVE SHAFT FOR RIA 2 520MM
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22009073
• Report Number: 8030965-2025-04751
• Device Sequence Number: 12101333
• Product Code: HTO
• UDI-Device Identifier: 10886982274243
• UDI-Public: (01)10886982274243(10)H887254
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K111437
• 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,Followup,Followup

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: 03.404.035
• Device Lot Number: H887254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 05/20/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 05/15/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2020
• 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