MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEM2.7MM B/T/B XPIN; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	210127
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint device was received and evaluated.Visual observation confirms the reported failure that the tips of the sleeve is broken and heavily damaged.The device also appeared to be in worn condition and possibly has seen heavy use.This type of failure is consistent with excess force being exerted during use of the device damaging the tip.This failure can be attributed to user technique.A review into the depuy synthes mitek complaints system revealed no similar complaint of any kind for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.A non-conformance search was performed for this product code 210127-lot #l328685 combination and no non-conformances were identified.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.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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure of the knee, it was observed that the external tip on the rigidfix fem2.7mm b/t/b xpin device broke when removing one of the two sleeves after the placement of the pins.According to the reporter, the event prevented the removal of the sleeve with the clamp provided.It was reported that the surgeon had to use another clamp.There were no patient consequences.There was no need to use another kit.It was reported that during placing, the surgeon had to force abnormally on the sleeve and he had difficulty to place and remove the interlocking trocar.There was a delay of five minutes in the surgery.It was reported that the tip of the sleeve did not fall into the patient.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: RIGIDFIX FEM2.7MM B/T/B XPIN
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8277826
• Report Number: 1221934-2018-53809
• Device Sequence Number: 16525835
• Product Code: MAI
• UDI-Device Identifier: 10886705000883
• UDI-Public: 10886705000883
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2017

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: 01/31/2020
• Device Catalogue Number: 210127
• Device Lot Number: L328685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1