MAUDE Adverse Event Report: SYNTHES GMBH GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.111.600
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent orif for distal radius fracture with the products in question.After about three locking screws was inserted in the plate distal hole, the surgeon tried to attach a quick drill sleeve in question to the second row proximal hole on the radial side, but he could not attach.He tried several times but just couldn't get the quick drill sleeve to attach.The guiding block was removed and the screw was inserted using a drill sleeve in va fixation mode.The surgery was completed successfully without any surgical delay.After the surgery, the sale rep inspected the instruments and found that only that hole could not attach the quick drill sleeve.Since other holes and different guiding blocks could be attached without any problem, it is thought that the hole proximal to the second row on the radial side of the guiding block was deformed.No further information is available.This report is for a guide block for 2 column plate 6 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: device available for evaluation: 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.
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.H10 additional narrative: h3, h6: 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.D10: date of concomitant therapy is (b)(6) 2023.
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.H10 additional narrative: h3, h4, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that two of the holes of the guidingblock f/2-column dist-rad-pl2.4 6 that mate with the quick drill sleeves where deformed.The edge of one of them was deformed outwards creating a burr onto the other one, preventing the quick drill sleeve to engage with the guiding block.A dimensional and functional tests for the guidingblock f/2-column dist-rad-pl2.4 6 were performed with pin gauges, and met specifications for all the holes except "va5".The complaint condition was able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the guidingblock f/2-column dist-rad-pl2.4 6 would contribute to the complained device issue.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 : 03.111.600.Lot no : 170149-101.Release to warehouse date: 17 july, 2017.Manufacturing site: werk selzach.Supplier: (b)(4).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 FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 16351306
• Report Number: 8030965-2023-01654
• Device Sequence Number: 15174000
• Product Code: FZX
• UDI-Device Identifier: 10886982072467
• UDI-Public: (01)10886982072467
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 03.111.600
• Device Catalogue Number: 03.111.600
• Device Lot Number: 170149-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 02/18/2023; 04/04/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/09/2023; 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2017
• 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