MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEM 3.3MM S/T XPIN; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 210133

Device Problem Mechanical Jam (2983)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The expiration date is unknown.

Event Description

It was reported by the affiliate via fax that the rigidfix fem was stuck and the physician couldn`t remove one part from another.The case was completed using another product of the same type.There was no patient consequence reported.Additional information provided by the affiliate reported there was a 90 minute surgical delay due to the reported event.The affiliate reported surgeon had to removed all product from patient body and completed with another one set but different manufacturer.Products will be returned for evaluation.

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 additional information should become available, a supplemental medwatch will be submitted accordingly.Udi:(b)(4).The expiration date is unknown.Investigation summary: the complaint device was not returned after multiple attempts for product return, by the customer, therefore, unavailable for a physical evaluation.This complaint cannot be confirmed.No non-conformances were identified for this part (210133)-lot number (l642023) combination as per qlik query executed (b)(6) 2019.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.

Event Description

Additional information provided by the affiliate reports: according to warehouse employee they just resend what received from customer but complaint has been reported on 1 product".Email attached.It was confirmed by the affiliate that lot number is l642025.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and evaluated.The reported failure could be confirmed from the visible mark on the trocar where it had cold welded with the sleeve.The location of the trocar interlocking pins is superior to the mating portion of the sleeve.If the pins are not seated within these groves then the trocar is spinning within the guide sleeve causing enough heat and friction to cause the welding of the two parts.The root cause for the reported failure is due to the user not locking the pins on the trocar into the grooves on the sleeve prior to starting the drill.The potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.No non-conformances were identified for this part (210133)-lot number (l642025) combination as per qlik query executed 06/20/2019.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.Udi (b)(4).

• Brand Name: RIGIDFIX FEM 3.3MM S/T XPIN
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8444902
• MDR Text Key: 139594364
• Report Number: 1221934-2019-56666
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10886705000890
• UDI-Public: 10886705000890
• Combination Product (y/n): N
• PMA/PMN Number: K974341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 210133
• Device Lot Number: L642025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 04/16/2019; 06/23/2019
• Supplement Dates FDA Received: 05/07/2019; 06/24/2019
• Patient Sequence Number: 1