MAUDE Adverse Event Report: SYNTHES GMBH 11.0MM REAMER HEAD FOR RIA 2 STERILE

Model Number	03.404.018S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
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.Additional product code: hrx.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Patent identifier: patient identifier: (b)(6).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) 2023, this patient was undergoing a revision surgery of the tibia.The original surgery was done by another surgeon and a non synthes plate and screws were used.The patient developed a non union of the distal tibia from the original surgery.Surgeon removed the non synthes plate and non synthes screws in order to address the tibial non union.Once the hardware was removed dr.(b)(6) reduced the non union and used the ria 2 ream out the tibia before implanting a tibial nail.As he started using the ria 2 it was noticed the the bone was very hard and took a lot of force to advance the reamer head.Surgeon advanced and retracted the reamer several times and the angle needed to ream the canal was more than normal due to the patient also having a total knee implant in place.As the reamer head entered the isthmus it was noticed that the reamer head had come off of the drive shaft in the canal.The reamer head was retrieved using the ball tipped reaming rod and the reaming was completed using the standard flexible reamer set.It was noticed under xray that two small metal pieces remained in the canal after reaming.The pieces were not attempted to remove and the procedure was completed as expected.The surgery was successfully completed without any surgical delay.The patient outcome was unknown.This report is for one (1) 11.0mm reamer head for ria 2 sterile.This is report 1 of 1 for complaint (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 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 the prongs of the 11.0mm reamer head for ria 2 sterile are broken off.The fragment was not returned.No other issue was identify.Embedded device condition cannot be confirmed as x-ray evidence or photos were not provided.A dimensional inspection for the 11.0mm reamer head for ria 2 sterile was not performed to 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 11.0mm reamer head for ria 2 sterile would contribute to the complained device issue.No new malfunctions were observed during this investigation that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed? yes, reviewed.Dimensional inspection: n/a.Device history lot manufacturing location: supplier ¿ mark two engineering / inspected and packaged by: monument release to warehouse date: 09-mar-2022 expiration date: 31-jan-2032 part number: 03.404.018s, 11mm reamer head for ria 2-sterile lot number: 574p807 (sterile) lot quantity: (b)(4).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.Component part(s) reviewed: part number: 03.404m018, ria ii reamer head 11.0mm lot number: 328p884 lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of compliance received from mark two engineering dated 23-nov-2021 was reviewed and determined to be conforming.Certification for heat treat supplied to mark two engineering from vacu-braze inc.Dated 10-nov-2021 was reviewed and determined to be conforming.Heat treat certified to be within specified range.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 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: 11.0MM 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: 16284388
• Report Number: 8030965-2023-01299
• Device Sequence Number: 6786049
• Product Code: HTO
• UDI-Device Identifier: 10886982273963
• UDI-Public: (01)10886982273963
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.404.018S
• Device Catalogue Number: 03.404.018S
• Device Lot Number: 574P807
• 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: 01/11/2023
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female