MAUDE Adverse Event Report: SYNTHES GMBH 8.5MM MEDULLARY REAMER HEAD

Catalog Number 352.085

Device Problem Break (1069)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown reaming rod/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 during a tibial nailing procedure while working on the middle part of the tibia, the rod got stuck and wasn¿t able to progress any further.This rod had been pushed back and forth multiple times before the reaming and this process (advancing the rod before reaming) took a long time.The rod was initially bent by the surgical team but was subsequently straightened out.When the rod was taken out it was discovered that the tip was missing.An incision was needed to retrieve the missing part but was removed successfully.The surgical team used another set to complete the procedure.This report is for one (1) unknown reaming rod.This is report 1 of 1 for (b)(4).

Event Description

The reamer head broke.

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.H10 additional narrative:.

• Brand Name: 8.5MM MEDULLARY REAMER HEAD
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11613366
• MDR Text Key: 243772614
• Report Number: 8030965-2021-02586
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.085
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - REAMING RODS
• Patient Outcome(s): Required Intervention