MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL RETROREAMER (6-12MM); CANNULATED SURGICAL DRILL, SINGLE-USE

Catalog Number 232000

Device Problem Device-Device Incompatibility (2919)

Patient Problem Joint Disorder (2373)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

It was reported by the affiliate that during an unknown procedure at (b)(6) hospital, while inserting the acl graft into the pre-drilled tunnel with the twistr reamer, it didn't fit correctly in.It was too tight and we couldn't remove the graft as it was already fixed with rigidloop implant.The tunnel seemed smaller than the graft.After surgery we inspected the twistr reamer and noticed that the blade doesn't open as much as the diameter was set during surgery (8mm).Additional information dated 08/24/2018 from the affiliate states the surgeon rescheduled the patient for another operation since the graft is not holding.The patient still suffers from an unstable knee and needs to be operated once again asap before complications occurs.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate udi: (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and functionally evaluated along with a npd engineer.No anomalies found during visual observation.As per functional testing, the diameter could be set to full range and the blade was able to be deployed and retract by turning the knob back."the customer reported that tunnel drilled by twistr reamer seemed smaller than the graft and was too tight that they could not removed the graft as it was already fixed with implant.Also, customer noticed that the blade doesn't open as much as the diameter was set during surgery.The reported failure can not be confirmed.The reported failure might be possible if the drill did not insert in the joint space up-to the laser line, which ensures the proper blade deployment.Another possible root cause could be the graft diameter was larger than the drilled tunnel diameter.Other than above mentioned possible root causes, we cannot discern any definite root cause at this point of time.Review of the device history record indicated that one unrelated issue to the reported failure.At this time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).

• Brand Name: RETROREAMER (6-12MM)
• Type of Device: CANNULATED SURGICAL DRILL, SINGLE-USE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 7912713
• MDR Text Key: 121844907
• Report Number: 1221934-2018-54741
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886705025626
• UDI-Public: 10886705025626
• 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,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 232000
• Device Lot Number: A1706001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Date Manufacturer Received: 11/21/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other