MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOKNOTLESS PLUS W/ ETHIBOND; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	212724
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Tissue Damage (2104); Foreign Body In Patient (2687)
Date of Event	04/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4) ¿ incomplete.Depuy mitek has been informed that the lot number is not available.
Event or Problem Description
It was reported via phone by the sales rep that during a shoulder procedure, the inserter tip on the customer's bio knotless plus anchor broke off.The sales rep was not present at the case and was not told if the fragment was removed.There were no patient consequences.The device is being returned.
Additional 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.Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.It was observed that the tip of the inserter was broken off.It is possible that when the anchor was successfully inserted into the bone hole, the user leveraged the inserter off axis thus causing the tip to break off.However, given the information provided we cannot discern a definitive root cause for the reported failure.No lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point, 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 not currently available.
Event or Problem Description
Additional information provided by the sales rep via email on 5-23-18 confirming that another anchor was used to complete the repair and rep was not at case and it was not confirmed to him whether implant was left in or taken out.

• Brand Name: BIOKNOTLESS PLUS W/ ETHIBOND
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7560624
• Report Number: 1221934-2018-51156
• Device Sequence Number: 19147872
• Product Code: MAI
• UDI-Device Identifier: 10886705002108
• UDI-Public: 10886705002108
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 212724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other