MAUDE Adverse Event Report: SYNTHES GMBH 11.5MM REAMER HEAD FOR RIA 2 STERILE

Catalog Number	03.404.019S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, the ria 2 was being used to harvest bone graft.The surgeon assembled the ria with direction from the sales consultant.They both heard an audible click when the ria shaft was inserted into the tube assembly and it was secure when tested with a light pull backwards.The ria head was snapped onto the end and was flush with the tube and shaft.The surgeon began to ream, and it was very difficult to advance the reamer.It sounded like metal was grinding, so the surgeon stopped and looked with x-ray.It was seen that the ria head was not attached to the drive shaft, and there were metal fragments in the femur canal.The ria was removed from the patient, and the ball tip guide wire was removed from the femur, pulling the ria head with it.A different drive shaft and new ria head was used to finish taking bone graft.The surgeon spent the next hour using small ling graspers and other instruments to fish the metal fragments out of the canal.The surgery was completed successfully with a 60-minute delay.It was very difficult and time consuming to remove the fragments, but they were all successfully removed.This report involves one 11.5mm reamer head for ria 2 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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional device product codes: hrx.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
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: manufacturing location: supplier ¿ (b)(4)/ inspected and packaged by: monument, release to warehouse date: 15-aug-2020, expiration date: 04-apr-2030, part number: 03.404.019s, 11.5mm reamer head for ria 2-sterile, lot number: 58p1764 (sterile), production order traveler met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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 the product that would contribute to this complaint condition.The radiograph was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned image.Visual analysis of the radiograph revealed that the distal prongs of the11.5mm reamer head for ria 2 sterile have broken.Fragments can be observed on the provided radiograph.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that 11.5mm reamer head for ria 2 sterile had the four prongs that assemble into the distal end broken, only one fragment was returned for evaluation.No other defects were observed.A dimensional inspection for the 11.5mm reamer head for ria 2 sterile was unable to be performed due to post manufacturing damage.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 13.5mm reamer head for ria 2 sterile would contribute to the complained device issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: 11.5MM REAMER HEAD FOR RIA 2 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: 17994622
• Report Number: 8030965-2023-13374
• Device Sequence Number: 17672913
• Product Code: HTO
• UDI-Device Identifier: 10886982273970
• UDI-Public: (01)10886982273970
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: 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: 03.404.019S
• Device Lot Number: 58P1764
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2020
• 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: UNK - RIA: DRIVE SHAFT
• Patient Age: 43 YR
• Patient Sex: Female