MAUDE Adverse Event Report: DEPUY MITEK LLC US FEM.INTFX SHEATH&SCRSYS,7.5MM; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE

Catalog Number	254681
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	08/31/2012
Type of Reportable Event	Malfunction
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: unknown.
Event or Problem Description
It was reported by the affiliate during a primary acl reconstruction, device was opened, and box was empty.Opened a second (different lot number) and sheath wouldn't deploy (unable to insert into patient).Opened a third to complete case.15 minute delay.No ae to patient.
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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary = > the device was received and evaluated.The complaint cannot be confirmed.Visual inspection was performed to reveal any gross visual defects that may contribute to the complaint condition.However,no visual defects were observed.As per the drawing the fem.Intfx sheath& scrsys,7.5mm was observed and no anomalies were observed.The reported condition was not confirmed and no defect was found.A non-conformance search was performed and no non-conformances were identified for this part number (254681) with lot number (3606605 ) combination per qlink search performed on 7/25/2019.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.Corrected data: (g4): date received by manufacturer.Udi:unknown.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device was received and evaluated.The complaint cannot be confirmed.Visual inspection was performed to reveal any gross visual defects that may contribute to the complaint condition.However,no visual defects were observed.As per the drawing the fem.Intfx sheath& scrsys,7.5mm was observed and no anomalies were observed.The reported condition was not confirmed and no defect was found.A non-conformance search was performed and no non-conformances were identified for this part number (254681) with lot number (3606605 ) combination per qlink search performed on 7/25/2019.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:unknown.

• Brand Name: FEM.INTFX SHEATH&SCRSYS,7.5MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8811494
• Report Number: 1221934-2019-57718
• Device Sequence Number: 11409879
• Product Code: MAI
• UDI-Device Identifier: 10886705013623
• UDI-Public: 10886705013623
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2012

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: 254681
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: 08/31/2012
• Supplement Date Received by Manufacturer: 07/25/2019; 07/25/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 07/26/2019; 07/29/2019
• Patient Sequence Number: 1