MAUDE Adverse Event Report: SYNTHES GMBH GUIDINGBLOCK F/2-COLUMN DIST-RAD-PL2.4 6; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.111.601
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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, the patient underwent the open reduction internal fixation for distal radius fractures.After drilling, the surgeon tried to insert a butt-less pin into the distal hole by using the drill sleeve, but the insert direction got to be a proximal downward.The surgeon tried to insert a butt-less pin again, but the result was the same.Finally, the surgeon removed the guiding block and inserted a butt-less pin.The surgery was completed successfully within 10 minutes delay.The drill sleeve was quite wobbled, so the inserting direction got to be improper direction.This report is for one (1) guide block for 2 column plate 7 hole head/right.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.Visual analysis of the returned sample revealed that no issues were identified with guidingblock f/2-column dist-rad-pl2.4 6.The dimensional inspection was not performed due to the complex geometry of the device.The functional test was performed to mount/assemble the drill sleeve on guiding block for all the guide holes.The guide sleeve was appropriately able to be interact with guiding block as desired.Thus device function as desired.The complete functionality of guiding block interaction cannot be performed due to absence of all the other mating device.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the guidingblock f/2-column dist-rad-pl2.4 6.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 # 03.111.700, lot # 10-3114, manufacturing site: werk selzach, supplier: (b)(4), release to warehouse date: 08 jul 2010.A manufacturing record evaluation was performed for the finished device lot number, 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: GUIDINGBLOCK F/2-COLUMN DIST-RAD-PL2.4 6
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): BACHLER FEINTECH AG; postfach; hölstein 4434 ; SZ 4434
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12805104
• Report Number: 8030965-2021-09485
• Device Sequence Number: 5484660
• Product Code: FZX
• UDI-Device Identifier: 07611819352544
• UDI-Public: 07611819352544
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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
• Device Catalogue Number: 03.111.601
• Device Lot Number: 10-3114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2010
• 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: QUICK DRILL SLEEVE 2.4 W/SCAL F/DRILL BI
• Patient Sex: Unknown