MAUDE Adverse Event Report: DEPUY MITEK LLC US GII QUICKANCHOR PANACRYL; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	212134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Associated mr#'s: (1221934-2018-53733); (1221934-2018-53735); (1221934-2018-53736); (1221934-2018-53737).
Event or Problem Description
Shoulder arthroscopy, (b)(6) 2018.It was reported that during the surgery the anchors were used for a fixation of the ligamentum patellae.When the surgeon wanted to tie the sutures, they broke.It happened to 5 anchors.Describe the 'damage' or 'other' outcome -the surgery took longer because they had to open a lot of new anchors.What action was taken/required to manage the problem during the procedure ? new anchors opened.How long was the procedure prolonged as a result of the difficulties encountered with the device(minutes)? 30 minutes.Has the reporter facility indicated there may be legal action? no.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Product complaint # (b)(4).Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.It was observed that the suture was frayed, and broken in two pieces.It is possible that the surgeon used excessive force when tying the suture therefore causing it to break.However, given the information provided we cannot discern a definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.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.Device history lot: no non-conformance was identified for this part/lot number combination per qlik query executed 11/29/2018.Review conducted per nr-0108348.Additional narrative: udi: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GII QUICKANCHOR PANACRYL
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7695462
• Report Number: 1221934-2018-53734
• Device Sequence Number: 1409587
• Product Code: JDR
• UDI-Device Identifier: 10886705001989
• UDI-Public: (01)10886705001989(10)L625659(17)220930
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K915889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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: 09/30/2022
• Device Model Number: 212134
• Device Catalogue Number: 212134
• Device Lot Number: L625659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1