MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM; SCREW,FIXATION,BONE

Model Number	02.211.040
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device procode: hrs.Device available for evaluation: device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluated by mfr, manufacture date: product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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) 2019, patient underwent an elective hardware removal due to malunion/nonunion.There were seven (7) plates and twenty-six (26) screws removed and it was removed successfully.Initial surgery was on (b)(6) 2018.There was no surgical delay.Procedure was successfully completed.Patient outcome was unknown.This event is captured under (b)(4).This report is for one (1) 2.7mm va locking screw.This is report 1 of 9 for (b)(4).
Event or Problem Description
There were seven (7) plates and twenty-six (26) screws removed.This complaint involves thirty-three (33) devices.This is report 1 of 9 for (b)(4).This complaint has been updated with the 21 of 33 devices.Please see the linked complaints (b)(4) for additional devices.
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 description updated.

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM
• 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: 8641427
• Report Number: 2939274-2019-58271
• Device Sequence Number: 11428780
• Product Code: HWC
• UDI-Device Identifier: 10886982053718
• UDI-Public: (01)10886982053718
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.211.040
• Device Catalogue Number: 02.211.040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 06/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 54