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	Foreign Body In Patient (2687)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint device was discarded and is not available for physical evaluation.The reported complaint cannot be confirmed.It was reported that the device was used with excessive force which may have potentially contributed to the reported breakage; however, a specific root cause cannot be determined.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.At this time, no corrective action is required and no further action is warranted.However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent to which this complaint is observed in the field.
Event or Problem Description
It was reported by the sales rep via phone that during an acl reconstruction procedure the customer's rigidfix cross pin kit metal sleeve broke off in the patient while it was being removed.The sales rep stated that the cross pins travel through the metal sleeves into the femur.The sales rep stated that the patient had hard bone and there was excessive force being used while the device was removed.The breakage occurred at the end of the case, so the procedure was completed with this device with no delay.The surgeon did not remove the metal piece from the patient, which the sales rep stated is no larger than three centimeters.There is no surgical intervention planned.The device was discarded by the customer.There was patient involvement reported.The status of the patient post-surgery was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional 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 is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A non-conformance search was performed for this product code 210127, lot l863127 combination and no non-conformance 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.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 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: 8150427
• Report Number: 1221934-2018-55638
• Device Sequence Number: 1333258
• Product Code: MAI
• UDI-Device Identifier: 10886705000883
• UDI-Public: 10886705000883
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 210127
• Device Lot Number: L863127
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other