MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC GUIDE BLOCK FOR 2 COLM PL 6 HOLE HEAD/RT; GUIDE, SURGICAL, INSTRUMENT

Model Number 03.111.600

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 Description

It was reported that the distal radius guide block was not threading on the plate and it looks like it was bent and cross threaded.There was no patient involvement.This report is for a distal radius guide block.This is report 1 of 1 for (b)(4).

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.H3, h6: a product investigation was conducted.Visual inspection: the guide block for 2 colm pl 6 hole head/rt (part #: 03.111.600, lot #: 09.9880) was received at us cq.Upon visual inspection, the set screw for the guiding block appeared bent.Functional test: a functional assessment was performed by unscrewing the set screw from the block.It was not able to unscrew as it gets stuck midway.The thread appeared stripped.Dimensional inspection: no dimensional inspection was performed due to the post manufacturing damage of the device.Document/specification review: relevant documents were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the visual inspection of the complaint device revealed that the set screw of the guiding block appear bent.The thread of the device also appeared to be stripped as the set screw could not be unscrewed all the way.Although no definitive root cause could be determined based on the provided information; it is likely that the device experienced unintended forces causing it to bent and damaging the thread.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: release to warehouse date: 29 jun 2009.Due to the age of more than 10 years of the complained device a wear or use related root cause is the most likely reason of the complained malfunction.Per franchise complaint product investigation procedure 100673626 is for complaints for which a non-manufacturing related probable cause has been identified no manufacturing record evaluation is required.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: GUIDE BLOCK FOR 2 COLM PL 6 HOLE HEAD/RT
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12172412
• MDR Text Key: 261933250
• Report Number: 2939274-2021-04098
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982072467
• UDI-Public: (01)10886982072467
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.111.600
• Device Catalogue Number: 03.111.600
• Device Lot Number: 09.9880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: DISTAL RADIUS