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

Model Number	210818
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the device, or further details are received at a later date, a supplemental medwatch will be sent.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.It was reported that the bone was hard, therefore, is a possible root cause of the reported problem.However, without the return of the complaint device, and no further information provided; we cannot determine a definitive root cause.A manufacturing record evaluation was performed for the finished device lot number (7l00268), and no non-conformances were identified.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).
Event or Problem Description
It was reported by the sales rep via phone that during an unknown procedure the versalok peek anchor with free strands of #2 orthocord cracked when malleting the bone.The sales rep stated that the bone was hard.Another device was used to complete the procedure.No patient consequences or surgical delay reported.The device was discarded by the staff.

• 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: 10677424
• Report Number: 1221934-2020-02988
• Device Sequence Number: 2823000
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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: 05/31/2025
• Device Model Number: 210818
• Device Catalogue Number: 210818
• Device Lot Number: 7L00268
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/14/2020
• Patient Sequence Number: 1