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

Model Number	351.706S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, the surgeon was using the ria 2 (reamer irrigator aspirator) bone harvesting kit and bits that go with it.A product representative was present for the procedure to ensure proper assembly and use of the product.During the procedure, shards of the bits kept breaking off in the patient¿s bone and were not able to be recovered.This issue happened with almost every device used in the procedure.When the kit was being withdrawn, pieces of what looked to be the plastic sheath shredded and taken out of the incision.Per the or note: we attempted to start reaming with the 10 mm synthes ria, however the reamer would not pass beyond the lesser trochanter.The ria was replaced with an 8.5 mm reamer.The reamer was advanced without difficulty over the ball-tipped guide rod to the distal femoral physis.The 10 mm ria was again used.The reamer was advanced to the level of the distal femoral physis and during extraction it was noted that the cutting had had separated from the reamer, leaving 2 small metal tines behind in the femoral diaphysis which were irretrievable.A 10.5 mm ria reamer was advanced to proximally the middle of the diaphysis before the reamer failed to advance and the tines again broke leaving 2 additional irretrievable times within the proximal femoral diaphysis.A standard 10.5 mm reamer was advanced over the ball-tipped guide rod to the level of the distal femoral physis followed by an 11 mm reamer.An 11 mm ria was advanced to the level of the distal femoral physis to thoroughly irrigate and aspirate the femoral canal.During extraction the tines of the reamer again broke leaving 2 additional metal fragments within the femoral canal.This report involves one (1) 2.5mm reaming rod with ball tip/950mm-sterile.This is report 5 of 6 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: b5: this report is against user facility medwatch number 2300380000-2023-8016, a copy is attached.D10 therapy date: april 10, 2023.D9: complainant part is not expected to be returned for manufacturer review/investigation.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 manufacturing location: supplier ¿ (b)(4) / inspected, packaged and released by: (b)(4).Release to warehouse date: 16-dec-2022 expiration date: 30-nov-2031.Part number: 351.706s, 2.5mm reaming rod with ball tip/950mm - sterile.Lot number: 2582p06.(sterile) lot quantity: (b)(4) production order traveler met all inspection acceptance criteria.Inspection certificate, 351.706-11-btq880013 / 1, met all inspection acceptance criteria.Certificate of conformance supplied by (b)(4) dated 23-nov-2022 was reviewed and determined to be conforming.Tensile strength specified as minimum 2000.Certified at 2195-2210.Tensile strength of ball tip specified at minimum of 1023.Certified at 1321-1571.Certification of heat treat supplied by temperature processing to eptam dated 04-nov-2022 was reviewed and determined to be conforming.Packaging label log (pll) lppf rev g, 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 24265 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.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿shards of (reamer) bits kept breaking off in the patient¿s bone¿ does not indicate breakage of the rod.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.Device history review: 17-may-2023: dhr reviewed by: mschoenfeld.This lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release of the 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: 2.5 REAMING ROD BALL TIP/950-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: 16987918
• Report Number: 8030965-2023-06525
• Device Sequence Number: 6852794
• Product Code: HTO
• UDI-Device Identifier: 10886982193858
• UDI-Public: 10886982193858
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 351.706S
• Device Catalogue Number: 351.706S
• Device Lot Number: 2582P06
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• 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: 10.0MM REAMER HEAD FOR RIA 2 STERILE.; 10.5MM REAMER HEAD FOR RIA 2 STERILE.; 11.0MM REAMER HEAD FOR RIA 2 STERILE.; RIA 2 BONE HARVESTING KIT 520MM STERILE.; RIA 2 BONE HARVESTING KIT 520MM STERILE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 31 KG