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

Catalog Number 232000

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem Not Applicable (3189)

Event Date 07/09/2019

Event Type  malfunction  

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.(b)(6).

Event Description

It was reported by the affiliate via email that the retroreamer has snapped during use.Procedure delay has been reported, no patient consequences.The breakage occurred whilst the surgeon was drilling a 3rd tunnel ¿ note only 2 tunnels are usually required but the surgeon changed his mind about the position of one tunnel and needed to drill a third also it was noted that the bone was particularly hard.Also during the same procedure one of the cords on a rigidloop adjustable snapped during positioning prior to final implantation.Additional information provided by the affiliate reported: it was reported by the affiliate via email that the retroreamer has snapped during use.Procedure delay of 30 minutes has been reported, no patient consequences.The breakage occurred whilst the surgeon was drilling a 3rd tunnel ¿ note only 2 tunnels are usually required but the surgeon changed his mind about the position of one tunnel and needed to drill a third also it was noted that the bone was particularly hard.Also during the same procedure one of the cords on a rigidloop adjustable snapped during positioning prior to final implantation.There were no fragments generated, the case was completed by using spare product and starting again with the graft preparation.There were no surgical interventions planned.

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.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.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.One possible root cause for the device breaking could be due to the reported hard bone of the patient, however with the information received, and without the return of the complaint device, we cannot determine a definitive root cause for the reported failure.At this point in 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).The lot number is unknown.

• Brand Name: RETROREAMER (6-12MM)
• Type of Device: CANNULATED SURGICAL DRILL, SINGLE-USE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8873441
• MDR Text Key: 156810201
• Report Number: 1221934-2019-57925
• 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
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 232000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• Patient Sequence Number: 1