MAUDE Adverse Event Report: SYNTHES GMBH SPARE REAMER TUBE FOR HOLLOW REAMER (309.035)

Catalog Number	309.038
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.Reporter is a synthes employee.A device history record (dhr) review was not conducted as manufacturing records related to the provided lot number were not available.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 sparereamertube f/309.035 had one of the serrated teeth broken, fragment was not returned.The reamer tube was received in assembled condition with the hollow reamer, they could not be separated.A dimensional inspection for the sparereamertube f/309.035 was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 sparereamertube f/309.035 would contribute to the complained device issue.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.Drawing/specifications reviewed the following drawings were reviewed: only current version spare reamer tube f/ 309.035 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
Device report from japan reports an event as follows: it was reported that on unknown date, the patient underwent revision surgery for plateau pseudoarthrosis.The surgeon used the hollow reamer to remove a broken cortex screw in bone.During use.The hollow reamer tube was broken.The surgeon confirmed this by imaging and direct observation and determined that there was no broken blade in the body.The surgery was completed successfully with no delay.This report is for a spare reamer tube for hollow reamer (309.035).This is report 2 of 2 for (b)(4) and captures the broken reamer tube.The broken screw is captured under (b)(4).

• Brand Name: SPARE REAMER TUBE FOR HOLLOW REAMER (309.035)
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16554735
• Report Number: 8030965-2023-03246
• Device Sequence Number: 12034296
• Product Code: HTO
• UDI-Device Identifier: 07611819201866
• UDI-Public: (01)07611819201866
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 309.038
• Device Lot Number: 2521288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2023
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HOLLOW-REAMER-COMPL ANTICLOCKWISE CUTTIN
• Patient Sex: Unknown