MAUDE Adverse Event Report: DEPUY MITEK MENISCAL APPLIER, OMNISPAN; ACL MENISCAL IMPLANTS

Catalog Number 228143

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Date 02/10/2015

Event Type  Injury  

Event Description

Backstop couldn't release by both applicators and all 3 needles.Instrument was inhibited.In this case the already release backstop must be removed.The surgeon must also remove a part of the meniscal.Surgery outcome was a partial meniscectomy instead repair.See associated medwatch # 1221934-2015-00639.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.

Manufacturer Narrative

This is a follow up report to document device return.A final report will be filed once the device has been investigated.

Event Description

Backstop couldn't release by both applicators and all 3 needles.Instrument was inhibited.In this case the already release backstop must be removed.The surgeon must also remove a part of the meniscal.Surgery outcome was a partial meniscectomy instead repair.See associated medwatch # 1221934-2015-00639.

Manufacturer Narrative

The complaint device was received by depuy synthes mitek and functional testing revealed the red trigger on the device was sticking and would not return to the ¿home¿ position.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident.Further, a review into the depuy synthes mitek complaints system revealed one other similar complaint for this lot of devices that were released to distribution.The complaint device was forwarded to the manufacturer for evaluation and root cause analysis.The manufacturer¿s investigation confirmed the trigger on the device would not fully return without assistance, confirming the complaint.The manufacturer confirmed that this product is 100% functionally activated by the assembly operator including trigger activation before packaging.During the complaint investigation attempts to simulate this failure mode were made, it appears that the gear assembly associated with the trigger might have been misaligned, not fully seated, and then slipped back into alignment but at a different gear location.Once moving freely the loading rod was visually short in deployed length indicating the gear which governs deployment length is out of location.The length was dimensionally verified to be short.It is possible that during assembly, the gear tooth was not fully seated, however it cannot be confirmed.An attempt at confirming this was made via a non-destructive test, a ct scan, which was performed on the device however the results were inconclusive.The manufacturer believes this device failure is an anomaly.The manufacturer has opened a capa as a result of this failure.No further action is warranted at this time, 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.

Event Description

Backstop couldn't release by both applicators and all 3 needles.Instrument was inhibited.In this case the already release backstop must be removed.The surgeon must also remove a part of the meniscal.Surgery outcome was a partial meniscectomy instead repair.See associated medwatch # 1221934-2015-00639.

• Brand Name: MENISCAL APPLIER, OMNISPAN
• Type of Device: ACL MENISCAL IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: david primmerman ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4560671
• MDR Text Key: 20018186
• Report Number: 1221934-2015-00638
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 228143
• Device Lot Number: 3795862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/10/2015
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2015
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other