MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR 12DEG; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228141

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: initial reporter is synthes sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date in 2019, during a knee arthroscopy with the first omnispan meniscal repair 12deg the surgeon fired the first implant behind the meniscus.The second implant fell off the needle before penetrating the meniscus for the second time.With the second needle the first implant was in place again.The second needle was fired and came out of the meniscus.A fifteen (15) minute delay was reported because they had to open new products which were not in the room.No additional information provided.This report is for one (1) omnispan meniscal repair 12deg.This is report 1 of 2 for (b)(4).

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.H10 additional narrative: h3, h4, h6 investigation summary the complaint device is not being returned, it was discarded, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.No non-conformances were identified for this part-lot number combination per qlik query executed on 11/06/2019.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.Device history no non-conformances were identified for this part-lot number combination per qlik query executed on 11/06/2019.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.

• Brand Name: OMNISPAN MENISCAL REPAIR 12DEG
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9214002
• MDR Text Key: 168190696
• Report Number: 1221934-2019-59110
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705010035
• UDI-Public: (01)10886705010035
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2021
• Device Model Number: 228141
• Device Catalogue Number: 228141
• Device Lot Number: 2L16257
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2019
• Patient Sequence Number: 1