MAUDE Adverse Event Report: DEPUY MITEK LLC US SUPER QA+ #2 ETH CP-2 *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	212032
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Tissue Damage (2104); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
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.Udi: (b)(4).The expiration date is not currently available.Associated medwatches: 1221934-2018-54454, 1221934-2018-54455, 1221934-2018-54453.
Event or Problem Description
It was reported by the customer using mitek super anchors in surgery last week that the anchor sutures had broken off exceptionally easily in 4 anchors.This has not happened in the past.There was patient consequence.Additional information received on 7/12/2018: surgeon had performed open hamstring operation to a patient.The anchor sutures had broken off exceptionally easily in 4 anchors.This resulted that surgeon had to apply 2 more different anchors, so there is more metal anchors in patient compared to normal.Also the surgery was delayed.This patient was operated last week, so the healing of the patient remains to be seen.The products are not available because the sutures were discarded and the metal parts were left to 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 is not available for physical evaluation, hence, the complaint cannot be confirmed.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.Udi: (b)(4).Associated medwatch report number: 1221934-2018-54453, 1221934-2018-54454, and 1221934-2018-54455.

• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7765866
• Report Number: 1221934-2018-54456
• Device Sequence Number: 19103727
• Product Code: JDR
• UDI-Device Identifier: 10886705001804
• UDI-Public: 10886705001804
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K930893
• 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): 07/10/2018

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: 12/31/2022
• Device Catalogue Number: 212032
• Device Lot Number: L746178
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 11/29/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other