MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR 27DEG; FASTENER,FIXATON,BIODEGRADABLE, SOFT TISSUE

Model Number 228142

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

Additional product codes hty;jdr;mbi;gat;new.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 during a meniscus repair after the first firing the 2nd plate was also deployed with the omnispan meniscal repair.Another device was used to complete the surgery.There were no adverse consequences to the patient.The surgery time was not delayed.No additional information could be provided.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The complaint device is not being returned, it was implanted in the patient, 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 number, lot number combination per qlik query executed on 8/19/2019.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.No non-conformances were identified for this part number, lot number combination per qlik query executed on 8/19/2019.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 27DEG
• Type of Device: FASTENER,FIXATON,BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9009338
• MDR Text Key: 183796749
• Report Number: 1221934-2019-58274
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705010042
• UDI-Public: (01)10886705010042
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 228142
• Device Catalogue Number: 228142
• Device Lot Number: L954304
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2019
• Patient Sequence Number: 1