MAUDE Adverse Event Report: SYNTHES GMBH REAMER HEAD F/RIA 2 Ø10

Catalog Number	03.404.016S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
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 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: 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
It was reported on (b)(6) 2025, while reaming the femur with ria 2, the head broke off into pieces within the femur.Additional x-ray was required to remove the pieces with a laparoscopic needle driver.All pieces were removed.A 45 minute delay occurred due to the reported event.Procedure was successfully completed.
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: d9.Photo investigation: the product was not returned to medtech orthopaedics , however photos were provided for review.See attachment (img_6209.Jpeg, img_6210.Jpeg).The photo investigation revealed that 03.404.016s, reamer head f/ria 2 ø10,has been broken.The observed condition of the device was consist with a random component failure that may have been caused by exposure to unintended force.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the reamer head f/ria 2 ø10, would contribute to the complained device issue.Based on the investigation findings, the reamer head f/ria 2 ø10 has broken because of cause trace to component failure , and 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 complaint condition.As part of medtech orthopedics 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.Device history lot: manufacturing location: supplier ¿ mark two engineering / inspected and packaged by: monument.Release to warehouse date: 08-sep-2021.Expiration date: 31-jul-2031.Part number: 03.404.016s, 10.0mm reamer head for ria 2-sterile.Lot number: 342p103 (sterile).Lot quantity: (b)(4).Nonconformance noted: n/a.Review of the dhr file: production order traveler met all inspection acceptance criteria.Packaging label log (pll) lppf rev a, lmd rev a was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 20572 supplied by sterigenics was reviewed and determined to be conforming.A manufacturing record evaluation was performed for the finished device with batch number 342p103.No nonconformities or manufacturing irregularities have identified related to the complaint condition.Component part(s) reviewed: part number: 03.404m016, ria ii reamer head 10.0mm.Lot number: 96p9107.Lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns073690 rev b met all inspection acceptance criteria.Certificate of compliance received from mark two engineering dated 28-jul-2021 was reviewed and determined to be conforming.Certification for heat treat supplied to mark two engineering from vacu-braze inc.Dated 06-jul-2021 was reviewed and determined to be conforming.Heat treat specified at 50-55 hrc.Results certified at 53 hrc.Certificate of analysis supplied to mark two engineering from banner medical dated 11-sep-2020 was reviewed and determined to be conforming.Raw material certification supplied to banner medical from dunkirk specialty steel dated 13-aug-2020 was reviewed and determined to be conforming.Device history review: 31-oct-2025: dhr reviewed by: (b)(4); a manufacturing record evaluation was performed for the finished device with batch number 342p103.No nonconformities or manufacturing irregularities have identified related to the complaint condition.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: d9 h3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found all four of the end prongs were broken apart.Only three broken fragments were returned for analysis.The fracture surface was examined, and no issues related to material was observed.The cause of this issue was identified as deviation from the recommended surgical approach of 10 degrees.Surgical technique se_828354 rev.Ac was reviewed and the following relevant statements were found at page 5: open the medullary canal and conduct reaming by following ao reaming techniques for im nailing and maintain a guide wire entry angle of less than 10° from the axis of the canal.Precaution: if the guide wire entry angle is greater than 10° from the axis of the canal, there is a risk that bowing of the reaming rod will result in: ¿ eccentric reaming of the far cortex.¿ damage to the reamer head connection, resulting in metal fragments in the canal.Notes: for an antegrade femoral approach, if possible, adduct the limb/hip to facilitate access to entry point.For greater trochanter entry point, target >2 cm distal to the lesser trochanter.For an antegrade tibial approach, the knee will need to be flexed to 90-110° for entry site access.Insert the guide wire aiming down the tibial crest, and thus the center of the medullary canal.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 reamer head f/ria 2 ø10 would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to user.As part of depuy synthes 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.Device history lot = > manufacturing location: supplier ¿ mark two engineering / inspected and packaged by: monument release to warehouse date: 08-sep-2021 expiration date: 31-jul-2031 part number: 03.404.016s, 10.0mm reamer head for ria 2-sterile lot number: 342p103 (sterile) lot quantity: (b)(4).Nonconformance noted: n/a.Device history review = > a manufacturing record evaluation was performed for the finished device with batch number 342p103.No nonconformities or manufacturing irregularities have identified related to the complaint condition.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: REAMER HEAD F/RIA 2 Ø10
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• 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: 23533335
• Report Number: 8030965-2025-11319
• Device Sequence Number: 9065974
• Product Code: HTO
• UDI-Device Identifier: 10886982273932
• UDI-Public: (01)10886982273932(17)310731(10)342P103
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K993335
• 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,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: 03.404.016S
• Device Lot Number: 342P103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 11/18/2025; 12/08/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 11/19/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 17 YR
• Patient Sex: Male