MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP POSTLAT DHP-LAT SUPT 3H/LT/75MM-SHORT; PLATE, FIXATION, BONE

Model Number	02.117.103
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: hwc.Complainant part is not expected to be returned for manufacturer review/ investigation.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) 2021, while performing a distal humerus, the surgeon had to re-adjust locking screws multiple times on a variable angle-locking compression plate (va-lcp) posterolateral distal humerus plate while trying to achieve reduction of the small fragments.Ultimately one or two of the 2.7 variable angle (va) locking screws did not engage in a plate.Surgeon decided to leave these holes empty.He determined that he had likely damaged the holes re-inserting the screws multiple times.Also while reducing, an adjustment nut fell off of the reduction forceps.The procedure was completed successfully with a surgical delay of ten (10) minutes.There was no patient consequence.This report is for one (1) 2.7mm/3.5mm va-lcp postlat dhp-lat supt 3h/lt/75mm-short.This is report 1 of 3 for complaint (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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Product was not returned.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.

• Brand Name: 2.7MM/3.5MM VA-LCP POSTLAT DHP-LAT SUPT 3H/LT/75MM-SHORT
• 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: 12350626
• Report Number: 2939274-2021-04788
• Device Sequence Number: 4068026
• Product Code: HRS
• UDI-Device Identifier: 10886982035882
• UDI-Public: (01)10886982035882
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: 02.117.103
• Device Catalogue Number: 02.117.103
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/17/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWDRIVERS; UNK - SCREWS: 2.7 MM VA LOCKING; UNK - SCREWS: 2.7 MM VA LOCKING
• Patient Age: 45 YR
• Patient Weight: 111