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

Catalog Number	232000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during an acl procedure the cannula portion of the customer's twistr reamer (6-12 mm) malfunctioned, the top of it broke.The sales rep stated that all the debris was removed from the patient with a shaver and no debris was left in the patient.The procedure was completed with the same device using the reamer portion as they were near the end of the case.There was no patient harm but there was a 45 minute surgical delay to the case.The device will be returning for evaluation.
Additional Manufacturer Narrative
Product complaint # = > pc-(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 = > according to the information provided, it was reported that the cannula malfunctioned, the top of was broken.The complaint device was received and evaluated.Visual observations confirm that the top pf the cannula was broken and fully separated, confirming this complaint.The possible root cause for the reported failure can be attributed to normal wear use and tear.However this cannot be conclusively affirmed.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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).

• Brand Name: RETROREAMER (6-12MM)
• Common Device Name: CANNULATED SURGICAL DRILL, SINGLE-USE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9519800
• Report Number: 1221934-2019-60123
• Device Sequence Number: 16280317
• Product Code: HTO
• UDI-Device Identifier: 10886705025626
• UDI-Public: 10886705025626
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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 Expiration Date: 06/30/2020
• Device Catalogue Number: 232000
• Device Lot Number: A1707011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 01/17/2020
• Patient Sequence Number: 1