MAUDE Adverse Event Report: SYNTHES GMBH SYNREAM REAMER HEAD Ø11.5

Catalog Number	352.115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: reporter is a j&j employee.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent the intramedullary insertion surgery using etn for tibial shaft fracture with the medullary reamer head in question.In the surgery, the k-wire was used as blocker pin to guide the insertion position of the reaming rod.The reaming head contacted with the blocking pin during reaming, and the cutting edge was worn.No residue was found in the body, and the surgery was continued at the discretion of the surgeon.The surgery was completed successfully without any surgical delay.This report is for one (1) synream reamer head ø11.5 this is report 2 of 2 for complaint (b)(4).

• Brand Name: SYNREAM REAMER HEAD Ø11.5
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14316548
• Report Number: 8030965-2022-03008
• Device Sequence Number: 5000779
• Product Code: HTO
• UDI-Device Identifier: 07611819243750
• UDI-Public: (01)07611819243750
• 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
• Report Date (Section B): 05/06/2022

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: 352.115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/07/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNREAM REAMER HEAD Ø11; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - NAILS: EXPERT TIBIAL
• Patient Sex: Unknown