MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HEALIX AV PK 5.5 TAPE WHT/BLUE; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222366
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	09/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4)-incomplete.The exp date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during a rotator cuff repair surgical procedure, it was observed that the healix advance anchor device broke at the tip.It was reported that the patient had a hard bone, and the insertion was slightly off axis.There was no delay in the surgical procedure as another same like product was used to complete the procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Event or Problem Description
Additional information received from affiliate on 04-october-2018: the anchor was not left in situ.It is believed another hole was made for the anchor.There was no adverse effect to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device was discarded by the customer therefore, device is not available for a physical evaluation.No pictures were provided.This complaint is not confirmed.As reported their healix advance anchor broke at the tip.No fragments were left in the patient.No further information regarding the procedure or the device used has been provided to determine a root cause for this failure.A non-conformance search was performed for this part 222366 lot l946815 combination and no nonconformances were identified.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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 expiration date is not currently available.

• Brand Name: HEALIX AV PK 5.5 TAPE WHT/BLUE
• 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: 7994713
• Report Number: 1221934-2018-55023
• Device Sequence Number: 1488065
• Product Code: MBI
• UDI-Device Identifier: 10886705028009
• UDI-Public: 10886705028009
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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 Catalogue Number: 222366
• Device Lot Number: L946815
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other