MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK PEEK WITH ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	210818
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional 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.The complaint device was received and inspected.Visual observation of the device revealed no anomalies.The inserter assembly was loaded on an applier gun and tested using a sawbones model.The anchor deployed as intended.Hence the complaint cannot be confirmed.Visual observation revealed the crack at the proximate tip of the anchor.This might have caused due to off axis insertion, levering during insertion or using incorrect instrumentation for preparing bone hole.During investigation, our sales rep informed via email that while the resident deployed the anchor and she is thinking the gun may not have been locked, which lead to this event.Therefore the root cause of this reported failure is likely user error.Further a batch record review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.Depuy 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).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
The sales rep reported via phone that the customer's versalok peek w/orthcord did not deploy the implant during a rotator cuff repair.The case was completed with another like device.No new bone holes were created to complete the case.There were no patient consequences or delays.The sales rep was not present during the case and could not provide any more details.The device is being returned.Additional information received via email on 08-16-2017: when was the issue detected? during the case.Was there a resulting surgical delay - how long? no.Was the procedure able to be completed? yes.Were alternatives readily available? yes.Any patient impact? no.

• Brand Name: VERSALOK PEEK WITH ORTHOCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7796090
• Report Number: 1221934-2018-53945
• Device Sequence Number: 19420020
• Product Code: MAI
• UDI-Device Identifier: 10886705001323
• UDI-Public: 10886705001323
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2017

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: 04/30/2020
• Device Catalogue Number: 210818
• Device Lot Number: L374573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/18/2018
• Patient Sequence Number: 1