MAUDE Adverse Event Report: SYNTHES GMBH GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/LT; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.111.501
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent an unknown surgery.During the surgery, when the guiding block in question was attached to a plate, the guiding block was unstable.The surgeon reattached the guiding block to the plate, but the guiding block did not stabilize and remained unstable.The guiding block in question was compared to other sizes of guiding blocks, but it seemed nothing abnormal.In the surgery, the plate was inserted without using any guiding blocks.The surgery was completed successfully without surgical delay.The patient outcome was reported as stable.No further information is available.This report is for one (1) guide block for two-column plate/narrow 6h hd/lt.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
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.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.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.
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: part # 03.111.501.Synthes lot # 3290156.Supplier lot # n/a.Release to warehouse date: december 2, 2009.Manufactured by: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The product was returned to us cq for evaluation.The us customer quality (cq) team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the set screw component of the guidingblock f/2-column dist-rad-pl2.4 n had stripped threads.No other issues were identified.The dimensional inspection was not performed due to the post manufacturing damage.The observed condition of the guidingblock f/2-column dist-rad-pl2.4 n was consistent with a random component failure that may have been caused by cross threading or exposure to unintended/excessive forces.A functional test could not be performed as the mating device in question was not returned for evaluation.However, the mating issue reported can be confirmed as the set screw threads were found to have been stripped.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the guidingblock f/2-column dist-rad-pl2.4 n was observed to have the set screw component in the stripped condition.While no definitive root cause could be determined from the available information, it is probable that the threads of the set screw component of the guidingblock f/2-column dist-rad-pl2.4 n were stripped due to cross threading or exposure to unintended/excessive forces.There was no indication that a design or manufacturing issue contributed to the complaint.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? the following drawings reflecting the current and manufactured revisions were reviewed: guiding block for va-lcp, tcp narrow, 6 holes, left; set screw for guiding block.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 TWO-COLUMN PLATE/NARROW 6H HD/LT
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13114346
• Report Number: 8030965-2021-10546
• Device Sequence Number: 17021830
• Product Code: FZX
• UDI-Device Identifier: 07611819394414
• UDI-Public: (01)07611819394414
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 03.111.501
• Device Lot Number: 3290156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 01/10/2022; 03/01/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 01/31/2022; 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2009
• 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 - PLATES: TRAUMA
• Patient Sex: Unknown