MAUDE Adverse Event Report: SYNTHES GMBH 11.0MM MEDULLARY REAMER HEAD

Model Number	352.110
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2022
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.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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
Device report from canada reports an event as follows: it was reported that on (b)(6) 2022 during routine processing, medical device reprocessing staff identified the reamer heads in question had become dull and were no longer useful in performing their primary function.These items were discarded, and replacements were requested.No further information is available.This report is for a 11.0mm medullary reamer head.This is report 14 of 15 for (b)(4).

• Brand Name: 11.0MM MEDULLARY REAMER HEAD
• 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: 15618868
• Report Number: 8030965-2022-08302
• Device Sequence Number: 12756310
• Product Code: HTO
• UDI-Device Identifier: 10886982194220
• UDI-Public: (01)10886982194220
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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 Model Number: 352.110
• Device Catalogue Number: 352.110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: HANDLE WITH QUICK COUPLING, LENGTH 110 MM; SYNREAM REAMER HEAD Ø10; SYNREAM REAMER HEAD Ø10.5; SYNREAM REAMER HEAD Ø10.5; SYNREAM REAMER HEAD Ø11; SYNREAM REAMER HEAD Ø11.5; SYNREAM REAMER HEAD Ø11.5; SYNREAM REAMER HEAD Ø8.5; SYNREAM REAMER HEAD Ø8.5; SYNREAM REAMER HEAD Ø9; SYNREAM REAMER HEAD Ø9; SYNREAM REAMER HEAD Ø9.5; SYNREAM REAMER HEAD Ø9.5
• Patient Sex: Unknown