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

Catalog Number	222028
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).Investigation summary: the device is not being returned.The device is not available for physical evaluation and hence this complaint cannot be confirmed.No nonconformances were identified for this part number (222028), lot number (l973673) combination.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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 via phone that during a rotator cuff repair procedure the sales rep's 4.5mm healix advance peek anchor with dynacord broke after insertion.The sales rep stated the anchor is broken in the middle of the anchor.The sales rep stated the issue might have occurred because it was off axis during insertion.The sales rep stated the anchor was removed by pulling on the driver and the sutures to remove the whole anchor with no debris left behind.The case was completed by using another anchor in a new bone hole with no time delay.The sales rep stated there is no need for surgical intervention.The anchor was discarded by the customer.There was patient involvement reported.It was not reported if there was prolonged hospitalization.The status of the patient post-surgery was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 4.5HLX ADV PK ANC-DYNA STR/BL
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8074996
• Report Number: 1221934-2018-55324
• Device Sequence Number: 1721708
• Product Code: MBI
• UDI-Device Identifier: 10886705029426
• UDI-Public: 10886705029426
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K173859
• 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): 11/02/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 222028
• Device Lot Number: L973673
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1