MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC GUIDE BLOCK TWO-COLM PL/NARROW 6H HD/RT

Model Number	03.111.500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The 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 history lot: part # 03.111.500, lot # 3290316, release to warehouse date: jan 29, 2010, manufacturer: (b)(4), no ncr's were generated during production.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, the patient underwent for a surgery.The surgeon was putting on the narrow guide block for the variable angle distal radius plate, the threads broke off, and the post broke in half.The post was retrieved with a pick-up, they threaded another pair from the contralateral guide block into it.The case went on as normal with no issue.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) guide block two-colm pl/narrow 6h hd/rt.This report is 1 of 1 for (b)(4).

• Brand Name: GUIDE BLOCK TWO-COLM PL/NARROW 6H HD/RT
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12068222
• Report Number: 2939274-2021-03240
• Device Sequence Number: 4110542
• Product Code: FZX
• UDI-Device Identifier: 10886982072429
• UDI-Public: (01)10886982072429
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: No Information
• Device Model Number: 03.111.500
• Device Catalogue Number: 03.111.500
• Device Lot Number: 3290316
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/25/2021
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 65