MAUDE Adverse Event Report: SYNTHES GMBH GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT; 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	10/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent open reduction internal fixation for a distal radius fracture with the product in question.During the surgery, when the guide block was attached to the plate and retightened with a screwdriver, the handle was damaged and the tip of the handle was buried in the plate.The surgeon was able to remove the tip with radio pliers but was unable to use a guiding block, so he used a threaded drill guide.The surgery was complete successfully with a 30 minute delay.No further information is available.This report involves one guide block for 2 column plate 6 hole head/right.This is report 1 of 1 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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Occupation: reporter is a j&j employee.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.Part # 03.111.601, lot # 14-1589, manufacturing site: werk selzach logistik, release to warehouse date: 30 oct 2014.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 guidingblock f/2-column dist-rad-pl2.4 6 was broken from the fixing screw.Assembling issues are most likely due to this condition.A functional test was unable to be performed due to not being applicable to the complaint condition, a dimensional inspection for the guidingblock f/2-column dist-rad-pl2.4 6 was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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.Drawing/specifications reviewed: guiding block f/two-column drp 2.4 6 hole, left se_ (current) / rev.F (manufactured).Dimensional inspection: n/a.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): WERK SELZACH; postfach; hölstein 4434 ; SZ 4434
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15761793
• Report Number: 8030965-2022-09543
• Device Sequence Number: 18199954
• Product Code: FZX
• UDI-Device Identifier: 07611819352537
• UDI-Public: (01)07611819352537
• 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

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 Catalogue Number: 03.111.601
• Device Lot Number: 14-1589
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2014
• 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: UNK - HANDLES: TRAUMA
• Patient Sex: Unknown