MAUDE Adverse Event Report: SYNTHES GMBH 10.0MM REAMER HEAD FOR RIA 2 STERILE

Model Number	03.404.016S
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/19/2022
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 procode: hrx.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.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.Manufacturing location: supplier ¿ mark two engineering / inspected and packaged by: (b)(4).Release to warehouse date: 29-jun-2020.Expiration date: 01-jun-2030.Part number: 03.404.016s, 10.0mm reamer head for ria 2-sterile.Lot number: 60p2034 (sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Documentation supplied by sterigenics 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 the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 03.404m020, ria ii reamer head 12.0mm; lot number: 6982001; 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 27-apr-2020 was reviewed and determined to be conforming.Certification for heat treat supplied to mark two engineering from vacu-braze inc.Dated 18-mar-2020 was reviewed and determined to be conforming.Heat treat results were reviewed and determined to be conforming.Raw material certification supplied to mark two engineering from banner medical dated 25-nov-2019 was reviewed and determined to be conforming.Raw material certificate of tests supplied to banner medical from carpenter dated 11-jun-2019 was reviewed and determined to be conforming.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the attachment.Visual analysis of the photo revealed that there was no damage or defects with the 10.0mm reamer head for ria 2 sterile.The photos provided do not have enough evidence to confirm the reported allegation (broken or embedded device condition) or any other issue.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for 10.0mm reamer head for ria 2 sterile.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.
Event or Problem Description
It was reported that on (b)(6) 2022, while using the ria2 on an infected tibia the reamer head broke off.This occurred inside of the patient and left three fragments inside of the tibia.The procedure was completed successfully with 30 minutes of surgical delay.No further information is available.This report is for a 10.0mm 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.H3, h6: manufacturing location: supplier ¿ (b)(4)/ inspected and packaged by: monument release to warehouse date: 29-jun-2020 expiration date: 01-jun-2030 part number: 03.404.016s, 10.0mm reamer head for ria 2-sterile lot number: 60p2034 (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.Component part(s) reviewed: part number: 03.404m020, ria ii reamer head 12.0mm lot number: 6982001.Inspection instruction met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of compliance was reviewed and determined to be conforming.Certification for heat treat was reviewed and determined to be conforming.Material certification was reviewed and determined to be conforming.Raw material certificate of tests was reviewed and determined to be conforming.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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that there was no damage or defects with the10.0mm reamer head for ria 2 sterile.The photos provided do not have enough evidence to confirm the reported allegation (broken or embedded device condition) or any other issue.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for 10.0mm reamer head for ria 2 sterile.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 10.0MM 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: 15550741
• Report Number: 8030965-2022-07941
• Device Sequence Number: 19532128
• Product Code: HTO
• UDI-Device Identifier: 10886982273932
• UDI-Public: (01)10886982273932
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.404.016S
• Device Catalogue Number: 03.404.016S
• Device Lot Number: 60P2034
• 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: 09/19/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• 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: DRIVE SHAFT FOR RIA 2 520MM
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown