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

Model Number	03.111.500
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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, during a procedure the surgeon attempted to put a guide block and screw through the drill holes.The issue occurred while the attachment screw going to the patient's body via the guide block.We are doing a distal fibula plate for a patient and drilled for a locking screw then use the power shaft.The locking screw would not stick to the tip of the screwdriver shaft.Procedure was completed successfully with the hand screwdriver and a surgical delay of thirty(30) seconds.Concomitant device reported: unk - screws: distal radius: (part#unknown; lot# unknown; quality:1).This report is for one (1) guide block for two-column plate/narrow 6h hd/rt.This is report 1 of 6 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Investigation flow: functional.Visual inspection: the complaint device guiding block for two-column distal radius plate (product code: 03.111.500, lot number: 8236579) was returned to cq west chester for investigation.The device was returned without the setscrew and no visual defect was identified in the device during inspection.Functional test: a functional test could not be performed as the guiding block was returned without any screw or plate to evaluate the alignment of the device.The complaint could not be replicated during functional test.Dimensional inspection: a dimensional inspection could not be performed due to the design of the device.Document/specification review: based on the date of manufacture, the current and manufactured version of drawing were reviewed.Complaint confirmed: no, the complaint condition cannot be confirmed during physical device investigation but due to the missing set screw the overall complaint will be confirmed.Conclusion: the guide was returned without the setscrew and corresponding device to evaluate the complaint condition.Hence, the overall complaint was confirmed.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part: 03.111.500.Lot: 8236579.Manufacturing site: hagendorf.Supplier: n/a.Release to warehouse date: 06 february 2013.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 TWO-COLM PL/NARROW 6H HD/RT
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12665148
• Report Number: 2939274-2021-06180
• Device Sequence Number: 4479618
• Product Code: FZX
• UDI-Device Identifier: 10886982072429
• UDI-Public: (01)10886982072429
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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: 03.111.500
• Device Catalogue Number: 03.111.500
• Device Lot Number: 8236579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.8MM DRILL BIT/QC/165MM; 2.8MM THREADED DRILL GUIDE; LCP ONE-THIRD TUB PL COLLAR 10 H/117; SDDRIVE SCREWDRIVER SHAFT QC/T15; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - SCREWDRIVERS; UNK - SCREWS: CORTEX; UNK - TORQUE DEVICES; 2.8MM DRILL BIT/QC/165MM; 2.8MM THREADED DRILL GUIDE; LCP ONE-THIRD TUB PL COLLAR 10 H/117; SDDRIVE SCREWDRIVER SHAFT QC/T15; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - SCREWDRIVERS; UNK - SCREWS: CORTEX; UNK - TORQUE DEVICES
• Patient Sex: Unknown