MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM VA-LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 11MM; SCREW, FIXATION, BONE

Model Number	02.130.211
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: hrs.Initial reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
Event or Problem Description
It was reported that during an unknown surgical procedure on (b)(6) 2018, surgeon was attempting to remove a variable angle (va) locking screw.As the va locking screw was being backed out, it twisted and then broke.This report is for one (1) 1.5mm va locking screw.This is report 1 of 1 for (b)(4).
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.
Event or Problem Description
There was no previous synthes hardware in the patient.The nonunion occurred after an attempt to treat the fracture non operatively.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Updated initial reporter.Device was used for treatment, not diagnosis.
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.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.
Event or Problem Description
It was reported that on (b)(6) 2018, during open reduction and internal fixation second metacarpal nonunion, the surgeon had placed a variable angle (va) locking screw pre-drilled with appropriate underdrill.After removing the first screw he placed a second screw which was encountering a lot of resistance when inserting.Due to this, the screw head started to strip.Upon noticing this, the surgeon went to remove the screw and the screw head sheared off right at the base of the head.The surgeon attempted to remove the screw part remaining in the metacarpal, but since it was sunk below the cortical surface, it was left in the patient.There was no previous synthes hardware in the patient.The nonunion occurred after an attempt to treat the fracture non-operatively.There was a surgical delay of 20 minutes.Patient and procedure outcome are unknown.Concomitant device reported: unknown screw (part #: unknown lot #: unknown quantity: unknown) , unknown drill (part #: unknown lot #: unknown quantity: unknown).

• Brand Name: 1.5MM VA-LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 11MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8060538
• Report Number: 2939274-2018-54937
• Device Sequence Number: 1747900
• Product Code: HWC
• UDI-Device Identifier: 10886982044655
• UDI-Public: (01)10886982044655
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/24/2018

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 Model Number: 02.130.211
• Device Catalogue Number: 02.130.211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 11/20/2018; 12/19/2018; 12/19/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/10/2018; 12/20/2018; 12/20/2018
• Patient Sequence Number: 1
• Patient Age: 31 YR