MAUDE Adverse Event Report: DEPUY MITEK LLC US MENISCAL DEPLOYMENT GUN; ORTHOPAEDIC CERCLAGE APPLIER

Catalog Number 228143

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 06/01/2019

Event Type  Injury  

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).The lot number is unknown.

Event Description

It was reported via medwatch from received from fda.The surgeon was doing a knee scope with meniscal repair, loaded the omnispan meniscal repair 12 degree onto the deployment gun.As surgeon was adjusting gun to the correct location, metal tip of the repair system came off deployment gun and was loose in the patient's knee.The result was an additional small incision to remove the loose metal tip.

Manufacturer Narrative

Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : the meniscal deployment gun was received and evaluated.It was observed under magnification and observed that tip was broken.The complaint can be confirmed.From the information provided the root cause for the reported failure cannot be determined.No lot number was provided which precludes in conducting a manufacturing record evaluation.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).

• Brand Name: MENISCAL DEPLOYMENT GUN
• Type of Device: ORTHOPAEDIC CERCLAGE APPLIER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9305146
• MDR Text Key: 185525300
• Report Number: 1221934-2019-59477
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705010059
• UDI-Public: 10886705010059
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228143
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Date Manufacturer Received: 12/23/2019
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 108