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

Catalog Number	351.706S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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 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.
Event or Problem Description
It was reported that on (b)(6) 2024 during an unknown procedure, the reaming rods in question broke.The surgeon prefers a bend at the end of the reaming rod, and the rods broke when staff attempted to bend them.A third reaming rod of the same type was opened, and staff were able to bend it successfully.There was no adverse patient impact.The surgery was completed successfully with no surgical delay.No further information is available.This report is for a 2.5mm reaming rod with ball tip/950mm-sterile.This is report 2 of 2 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.H3,h4,h6 the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the tip of 2.5 reaming rod ball tip/950-sterile was broken.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 2.5 reaming rod ball tip/950-sterile would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed 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 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.H4,h6 manufacturing location: supplier ¿ (b)(4) / inspected, packaged and released by: monument.Release to warehouse date: 10-jan-2024, expiration date: 30-nov-2032, part number: 351.706s-us, 2.5mm reaming rod w/ball tip 950mm - sterile, lot number: 7650p66 (sterile).One piece was scrapped in cell at op #40, thermal rinse-load, after being dropped.Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection certificate, 351.706-11-btq880013 / 2, met all inspection acceptance criteria.Certificate of conformance supplied by (b)(4) dated 18-dec-2023 was reviewed and determined to be conforming.Tensile strength specified as minimum 2000.Certified at 2715.7.Tensile strength of ball tip specified at minimum of 1023.Certified at 1447.3 ¿ 1502.5.Packaging label log (pll), lppf rev g, and lmd rev c was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 27730 supplied by (b)(4) 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.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: 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18667080
• Report Number: 8030965-2024-02140
• Device Sequence Number: 8358237
• Product Code: HTO
• UDI-Device Identifier: 10886982193858
• UDI-Public: (01)10886982193858
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,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: 351.706S
• Device Lot Number: 7650P66
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5 REAMING ROD BALL TIP/950-STERILE
• Patient Sex: Unknown