MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC GUIDE BLOCK FOR 2 COLUMN PLATE 7 HOLE HEAD/LEFT

Model Number	03.111.701
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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 or Problem Description
It was reported that on (b)(6) 2019, the surgeon was unable to screw the aiming block for distal radius plate onto the plate.The attempt was made using different plates.The surgeon suggested that the screw might be stripped.There was no patient involvement.Concomitant device: distal radius plate (part: unknown, lot: unknown, quantity: unknown).This report is for a guide block for 2 column plate 7 hole head/left.This is report 1 of 2 for (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.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.
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.Additional narrative: h3, h6: part: 03.111.701; lot: 09-4511; manufacturing site: selzach; supplier: (b)(4); release to warehouse date: (b)(6) 2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the guide block for 2 column plate 7-hole head/left was received at us cq with the device showing minimal visual defects on the guide block.The set screw for the guide block has stripped threads.Under 5x magnification, the threads are extremely rounded.This is consistent with the reported complaint condition, thus confirming the complaint.Conclusion: the complaint condition is confirmed as the guide block was received with the threads of the set screw stripped.After a visual inspection per guidance, it is determined that the set screw is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 COLUMN PLATE 7 HOLE HEAD/LEFT
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8391814
• Report Number: 2939274-2019-56819
• Device Sequence Number: 1922149
• Product Code: FZX
• UDI-Device Identifier: 10886982072535
• UDI-Public: (01)10886982072535
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2019

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: 03.111.701
• Device Catalogue Number: 03.111.701
• Device Lot Number: 09-4511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 02/07/2019; 03/29/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 03/05/2019; 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE EVENT DESCRIPTION.