MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/12MM; PLATE,FIXATION,BONE

Model Number	04.501.112.01
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 on (b)(6) 2018, the patient underwent removal of the sternal locking screw.The reason for removal is because the screw was reported as loose.Surgical outcome and patient outcome are unknown.This report is for one (1) 3.0mm ti sternal lckng screw self-drilling/12mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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
Further it was reported that there was no surgical delay or medical intervention required.Patient outcome reported as planned.
Event or Problem Description
Concomitant device: f/sternal locking plate (part: 413.582, lot: unknown, quantity: 1).
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.Product investigation was completed.Visual inspection of the returned device revealed one of the two locking thread-starts was deformed.There were minor nicks to the threads.Functional testing could not be performed as the plate was not returned.However, the deformation noted to the start of the locking thread could contribute to the loose complaint condition.The major diameter of the locking threads measured 3.41mm, which was within specification of 3.5mm -0.02/-0.126 per drawing.Measured with ca802.The following drawing was reviewed: sternal unilock screw.During the investigation no product design issues were observed that may have contributed to the complaint condition.A device history records review could not be performed as the lot was unknown.The complaint condition of loose is considered confirmed due to the noted deformation to the locking thread start.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.There were no issues during the manufacture of this product that would contribute to this complaint condition.As it is unknown when or how the damage to the threads occurred, no definitive root cause could be determined.It is possible the threads were damaged preoperatively, during implantation, or during explantation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

• Brand Name: 3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/12MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7942932
• Report Number: 2939274-2018-54218
• Device Sequence Number: 1514268
• Product Code: HRS
• UDI-Device Identifier: 10887587017365
• UDI-Public: (01)10887587017365
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K093772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2018

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 Model Number: 04.501.112.01
• Device Catalogue Number: 04.501.112.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Received by Manufacturer: 09/15/2018
• Supplement Date Received by Manufacturer: 10/17/2018; 11/08/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 10/25/2018; 11/09/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention