MAUDE Adverse Event Report: DEPUY MITEK RAPIDLOC (PLA/PLA) 2/0 PANACRYL SUTURE WITH 12° CURVE NEEDLE; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 228321

Device Problems Bent (1059); Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.¿ (b)(4) incomplete.The expiration date is not currently available.Associated medwatch:1221934-2017-50062.

Event Description

Needle bent while drilling the meniscus, not being able to use later.Therefore, the doctor opened another needle from a different lot and the same thing happened.Two products affected.Another product was used.Procedure: meniscus suture.There was no damage to the patient.The procedure time was not prolonged due the event.

Manufacturer Narrative

Product complaint # (b)(4).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 was received and inspected.It was observed that the needle was bent on the distal end from the needle tip.This complaint can be confirmed.A member of new product development (npd) quality that is knowledgeable of the failures of this device was consulted for insight into the reported failure.The npd quality member indicated that this type of failure is unusual for this device, and may have occurred if the needle was forced against bone.Therefore, the device was potentially misused which led to the reported failure.No non-conformances were identified for this part-lot number combination.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices with the product code that were released to distribution.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) - incomplete.The expiration date is not currently available.Associated medwatch report number: 1221934-2017-50062.

• Brand Name: RAPIDLOC (PLA/PLA) 2/0 PANACRYL SUTURE WITH 12° CURVE NEEDLE
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS SARL; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 7118812
• MDR Text Key: 95797686
• Report Number: 1221934-2017-50063
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228321
• Device Lot Number: L230324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2017
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1