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

Catalog Number	03.111.601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: a1; patient id also reported as 9416437.H3, h6: part: 03.111.601 lot: 200257-101 manufacturing site: werk selzach logistik release to warehouse date: 08 march 2021 expiration date: n/a supplier: leitner ag a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was not returned to depuy synthes, however photos were received for review.The photo investigation revealed that '(03.111.601, guide block for 2 colm pl 6 hole hd/lft) had broken.The observed condition of the device was consist with a random component failure that may have been caused by exposure to unintended force.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was (confirmed) as the observed condition of the (guide block for 2 colm pl 6 hole hd/lfte) would contribute to the complained device issue.Based on the investigation findings, caused traced to component failure and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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 the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2024, the surgeon selected a 2.4 mm variable angle locking compression plate (va lcp)) two-column volar distal radius plate for a patient.The screw/pin on the left guide block snapped off while surgeon was attempting to thread the guide block onto the plate.No adverse affect to patient was caused by this event, however the guide block is now un-usable without the connecting screw/pin.Surgeon removed damaged equipment from sterile field and proceeded without using guide blocks.There was no surgical delay.Procedure successfully completed.There was no patient consequence.This report is for a guide block for 2 column plate 6 hole head/left.
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 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.H11 additional narrative: physical device investigation: h3, h4, h6: the product was returned to medtech orthopaedics for evaluation.Visual inspection of the returned device found the set screw for guiding bloc missing from the guidingblock f/2-column dist-rad-pl2.4 6.No other defects that could contributed to the reported event were identified., no evidence of brakeage were observed, therefore the reported allegation cannot be confirmed.Based on the information available, it is not possible to determine in which part of the process the components were missing.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was unconfirmed as the observed condition of the guide block for 2 colm pl 6 hole hd/lft would not contribute to the complained device issue.Based on the investigation findings, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that '(03.111.601, guide block for 2 colm pl 6 hole hd/lft) had broken.The observed condition of the device was consist with a random component failure that may have been caused by exposure to unintended force.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was (confirmed) as the observed condition of the (guide block for 2 colm pl 6 hole hd/lfte) would contribute to the complained device issue.Based on the investigation findings ,caused traced to component failure and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: part # 03.111.601 lot # 200257-101 manufacturing site: werk selzach logistik release to warehouse date: 08.March.2021 expiration date: n/a supplier:(b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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/LEFT
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20181020
• Report Number: 8030965-2024-11058
• Device Sequence Number: 8297973
• Product Code: FZX
• UDI-Device Identifier: 10886982072474
• UDI-Public: (01)10886982072474(10)200257-101
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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: 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 Catalogue Number: 03.111.601
• Device Lot Number: 200257-101
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 09/12/2024; 09/19/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 09/19/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2021
• 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 - PLATES: VA-LCP
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 61 KG