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	07/10/2019
Type of Reportable Event	Serious Injury
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.Udi: (b)(4).The expiration date is unknown.
Event or Problem Description
It was reported by the affiliate via cst that after the rigidfix fem2.7mm being inserted, the rigidfix btb cross pin sleeve was removed by using the sleeve removal tool.The surgeon realized that there was a piece missing when the cross pin sleeve was pulled out - it remained in the bone.By using radiography, this piece was identified, but not removed.The case was completed by using a milagro advance screw to fix the transplant in the femoral tunnel.No delay reported.The device was discarded additional information received from the affiliate reporting the device will not be returning for evaluation.
Additional 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.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.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.One possible root cause for the reported problem could be the excessive force applied while pulling out the cross pin sleeve resulting in the breakage of the device.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.No nonconformances were identified for this part-lot number combination per qlik query executed on 09/11/2019.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).The expiration date is unknown.

• 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: 8871796
• Report Number: 1221934-2019-57919
• Device Sequence Number: 502809
• Product Code: MAI
• UDI-Device Identifier: 10886705000883
• UDI-Public: 10886705000883
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 07/11/2019

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: 210127
• Device Lot Number: 3887279
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 09/30/2019
• Patient Sequence Number: 1