MAUDE Adverse Event Report: SYNTHES GMBH GUIDE BLOCK FOR 2 COLUMN PLATE 7 HOLE HEAD/RIGHT; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.111.700
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
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.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
Device report from japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent osteosynthesis surgery for left distal radius fracture.In the surgery, the guiding block was difficult to attach to the plate.After several tries, the surgeon attached the guiding block and manually tightened the connecting screw.When the back of the plate was observed, the tip of the connecting screw protruded from the back of the plate by about 3 mm.The surgeon decided that the protrusion was not within the allowable range and replaced it with the same part number guiding block.The issue did not repeat.The surgery was completed successfully with no delay.Patient was stable.This report is for a guide block for 2 column plate 7 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.H10 additional narrative: g1, h4 a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part:03.111.700 lot:09-4567 manufacturing site: werk selzach supplier: leitner ag release to warehouse date:21 dec 2009 expiration date: na 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 the [guidingblock f/2-column dist-rad-pl2.4 7] was stripped from the plate's inner threads.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.After a visual inspection per procedure, it was determined that the reusable instrument device was stripped from the inner threads of the plate from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.A functional test was performed between the screw and the mating plate and they could been assembled and disassembled, however there was a slight difficulty while assembling the components, is highly likely the damage observed contributed to the reported allegation.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 [03.111.700 / guidingblock f/2-column dist-rad-pl2.4 7 / 09-4567] would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GUIDE BLOCK FOR 2 COLUMN PLATE 7 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; bohackerweg 5; selzach 2425 ; SZ 2425
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16852229
• Report Number: 8030965-2023-05506
• Device Sequence Number: 12455247
• Product Code: FZX
• UDI-Device Identifier: 07611819352544
• UDI-Public: (01)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

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: 03.111.700
• Device Lot Number: 09-4567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2009
• 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 - INSERTION INSTR: CONCT/COUPLSCREW: TRAUMA.; UNK - PLATES: TRAUMA.
• Patient Sex: Unknown