MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 4.5HLX ADV PK ANC-DYNA STR/BL; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222028
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
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.Udi: (b)(4).The expiration date is currently unavailable.Investigation summary: pending follow-up.The complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (7l27311), and no non-conformances related to the reported complaint condition 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.
Event or Problem Description
It was reported by the sales rep that during a rotator cuff repair procedure on an unknown date, it was observed that the suture on the 4.5hlx adv pk anc-dyna str/bl device broke and was left implanted in the patient.A new hole was made for another like device to complete the procedure with a delay of five minutes.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: 4.5HLX ADV PK ANC-DYNA STR/BL
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 11825231
• Report Number: 1221934-2021-01550
• Device Sequence Number: 11027911
• Product Code: MBI
• UDI-Device Identifier: 10886705029426
• UDI-Public: 10886705029426
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 222028
• Device Catalogue Number: 222028
• Device Lot Number: 7L27311
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/14/2021
• 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: Required Intervention