MAUDE Adverse Event Report: SYNTHES GMBH 2.5 REAMING ROD BALL TIP/950-STERILE; REAMER

Catalog Number	351.706S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery on (b)(6) 2024, the reaming rod broke in the femoral canal while inserting the rfna nail.There was a surgical delay of 60-90 minutes.The broken rod was retrieved out of the proximal end of the femur.An additional incision was made to retrieve the rod.The procedure was successfully completed.It was reported that there was no patient consequence.This report involves one 2.5mm reaming rod with ball tip/950mm-sterile.This is report 1 of 1 for (b)(4).
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 h11 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history review (dhr): manufacturing location: supplier ¿ (b)(4) / inspected, packaged and released by: monument.Release to warehouse date: 31-jan-2024.Expiration date: 31-dec-2032.Part number: 351.706s-us, 2.5mm reaming rod w/ball tip 950mm - sterile.Lot number: 8326p10 (sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria apart from 12 parts scrapped for surface finish-buffing marks.Inspection certificate met all inspection acceptance criteria.Certificate of conformance supplied by (b)(4) dated 16-jan-2024 was reviewed and determined to be conforming.Tensile strength within specifications.Tensile strength of ball tip within specifications.Packaging label log (pll) and lmd was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn supplied by jabil abq was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of this product that would contribute to this complaint condition.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.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: 2.5 REAMING ROD BALL TIP/950-STERILE
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19701820
• Report Number: 8030965-2024-08372
• Device Sequence Number: 18060847
• Product Code: HTO
• UDI-Device Identifier: 10886982193858
• UDI-Public: (01)10886982193858
• Combination Product (Y/N): N
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 351.706S
• Device Lot Number: 8326P10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAILS: RFNA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown