MAUDE Adverse Event Report: DEPUY MITEK LLC US PERCANNULA SYSTEM; ARTHROSCOPIC DRAINAGE CANNULA

Catalog Number	222274
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was received and visually inspected.Visual observations revealed the distal end of the sleeve/out shaft is bent inwards.This damage to the device could potentially cause the anchor to break during insertion.It is unclear how or when the device was damaged.A possible root cause could be that the device was inserted with an angle or the device has hit a hard bone causing it to deform.Other than this possibility, we cannot discern a root cause for the reported failure.This complaint can be confirmed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.Based on the overall complaint rate and customer impact, at this point in time, 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.A review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.(b)(4).This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
This is report 1 of 2 for the same event.It was reported by the affiliate in the (b)(6) that during a partial cuff tear repair, the when inserting the anchor half way into the bone, it looked like the anchor broke.But the outer shaft of the percanule system show a dent on one site.Which may lead to think it cut the anchor off.You can also see that on the edge were the anchor broke of/ has been cut off.Luckily the part of the anchor which got into the bone, held and so the doctor could finish the repair.It was reported that the proximal part was being sent back (with cortical treads) as the distal part with the sutures remained in the patient.It was reported that the anchor seemed to be cut off (by the outer shaft of the percanula system) between the cortical and cancellous treads.The surgeon was satisfied enough to finish the procedure with it and with the remaining distal part of the anchor, cause it still had some fixation this failure did not extend the procedure time greater than 30 minutes because he finished the procedure with the first anchor (which partially remained in the patients bone).There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: PERCANNULA SYSTEM
• Common Device Name: ARTHROSCOPIC DRAINAGE CANNULA
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7901741
• Report Number: 1221934-2018-54729
• Device Sequence Number: 16531931
• Product Code: GEA
• UDI-Device Identifier: 10886705020263
• UDI-Public: 10886705020263
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K130917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2016

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: 04/30/2018
• Device Catalogue Number: 222274
• Device Lot Number: 3842601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2016
• Initial Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1