MAUDE Adverse Event Report: DEPUY MITEK LLC US RGDFIX 2.7MM BTB BR XPIN KIT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	210815
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the broken trocar was returned for this complaint.The other parts of the kit were not returned.Visual inspection confirms that the trocar is broken.The break occurred where the pin is placed in the shaft.There are visible striation marks on the trocar.Historically, this type of failure has been attributed to user technique issue.The location of the trocar interlocking pins is superior to the mating portion of the sleeve.If the pins are not seated within these grooves, then the trocar is spinning within the guide sleeve then when it seats properly the shaft will snap at the pin location.The section where the pin is placed in the trocar would be a weak point where we would expect to see this breakage if this condition was seen.This complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the reported complaint condition were identified.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).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during an acl reconstruction procedure the sales rep's rigidfix cross pin kit trocar broke while drilling the sleeve into the lateral condyle.The sales rep stated there was no patient harm.It is unknown if the case was completed successfully, if there was a time delay, or if fragments were created.
Additional 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.Udi: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RGDFIX 2.7MM BTB BR XPIN KIT
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8420318
• Report Number: 1221934-2019-56610
• Device Sequence Number: 16687062
• Product Code: MAI
• UDI-Device Identifier: 10886705001293
• UDI-Public: 10886705001293
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

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 Catalogue Number: 210815
• Device Lot Number: 165302R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 03/14/2019
• Patient Sequence Number: 1