MAUDE Adverse Event Report: SYNTHES GMBH UNK - REAMERS: REAMER HEAD

Catalog Number UNK - REAMERS: REAMER HEAD: TR

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown reamers: reamer head/unknown lot.Part and lot numbers 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during the procedure the reamer head broke.The fragment could not be removed from the femur due to the risk of complication.There was a twenty (20) minute surgical delay for guide repositioning.The procedure was completed successfully.There was no complication to the patient.This report involves one (1) reamers: reamer head.This is report 1 of 1 for (b)(4).

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.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.B4/g3: initial alert date should have been 12/10/2020.

Manufacturer Narrative

Product complaint # (b)(4).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.H10 additional narrative: b5: update provided for reporting.D11: concomitant product added to complaint.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 synthes reports an event in france as follows: it was reported that on (b)(6) 2020, during the procedure ablation of the alesoria, the reamer head broke.The fragment, (drilling head fixing blade ) could not be removed from the femur due to the risk of complication.There was a twenty (20) minute surgical delay for guide repositioning.The procedure was completed successfully.There was no complication to the patient.Concomitant device reported: unk - reamers: reamer head, lot & qty unknown.This report involves one (1) reamers: reamer head.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - REAMERS: REAMER HEAD
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11141092
• MDR Text Key: 225823543
• Report Number: 8030965-2021-00196
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - REAMERS: REAMER HEAD: TR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2021
• Patient Sequence Number: 1
• Treatment: UNK - REAMERS: REAMER HEAD.
• Patient Outcome(s): Required Intervention