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

Model Number	03.404.019S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: it was reported that on (b)(6) 2023, the event involved the ria 2 reamer system and a 11.5 reamer head where the cons that hold the reamer head on to the reamer shaft broke off inside the patient.Patient was not harmed they were able to retrieve all of the metal cons.This complaint involves two (2) devices.Complainant part is not expected to be returned for manufacturer review/investigation.The instrument(s) was not returned and instead the investigation is done based on the supplied image(s).The photo was returned to depuy synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned device.Visual analysis of the photo revealed that the prongs of the 11.5mm reamer head for ria 2 sterile were broken.The broken fragments were observed in the visual evidence provided.No other issue was identify.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 synthese quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for 11.5mm reamer head for ria 2 sterile.The cause of this issue was identified as deviation from the recommended surgical approach of 10 degrees.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation cannot be performed due to lot number being unknown.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, the event involved the ria 2 reamer system and a 11.5 reamer head where the cons that hold the reamer head on to the reamer shaft broke off inside the patient.Patient was not harmed they were able to retrieve all of the metal cons.This complaint involves one (1) device.This report is for one (1) 11.5mm 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.Additional narrative: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that the prongs of the 11.5mm reamer head for ria 2 sterile were broken.The broken fragments were observed in the visual evidence provided.No other issue was identify.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 confirmed for 11.5mm reamer head for ria 2 sterile.The cause of this issue was identified as deviation from the recommended surgical approach of 10 degrees.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this 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
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16522998
• Report Number: 8030965-2023-03041
• Device Sequence Number: 19456179
• Product Code: HTO
• UDI-Device Identifier: 10886982273970
• UDI-Public: (01)10886982273970
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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 Model Number: 03.404.019S
• Device Catalogue Number: 03.404.019S
• Device Lot Number: 3048P17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; UNK - RIA: DRIVE SHAFT
• Patient Age: 64 YR
• Patient Sex: Male