MAUDE Adverse Event Report: DEPUY MITEK LLC US RAPIDLOC (PDS/PLA) 2/0 PANACRYL 12 DEGREE CURVE NEEDLE; SOFT TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	228311
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.Udi: (b)(4).
Event or Problem Description
Physician reported that during surgery procedure suture has been broken.To procedure completed physician used another one product the same type.No consequences for the patient reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A device history 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; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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.We cannot discern a root cause for the reported failure mode.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).
Event or Problem Description
Physician reported that during surgery procedure suture has been broken.To complete the procedure, the physician used another product of the same type.No consequences for the patient reported.Additional information received on 4-20-2018.The complaint device will not be returned.It was sent for destruction on customer site.The physician is not able to provide any more details regarding the event.

• Brand Name: RAPIDLOC (PDS/PLA) 2/0 PANACRYL 12 DEGREE CURVE NEEDLE
• Common Device Name: SOFT TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7338385
• Report Number: 1221934-2018-50298
• Device Sequence Number: 18962436
• Product Code: MAI
• UDI-Device Identifier: 10886705010196
• UDI-Public: 10886705010196
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 228311
• Device Lot Number: L187192
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1