MAUDE Adverse Event Report: SYNTHES GMBH BLADE/SCREW GUIDE SLEEVE; GUIDE, SURGICAL, INSTRUMENT

Model Number 03.037.017

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2023

Event Type  malfunction  

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: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h6: 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 Description

It was reported that on an unknown date, while getting set up for a tfna, the scrub tech noticed the buttress compression nut was still connected to the blade/screw guide sleeve.The scrub tech tried to remove the buttress nut but was unsuccessful.The rep gave the nurse a new instrument set, and the tech handed off the other one.The rep tried after the case to remove the nut, but it would not budge.The rep believes this instrument is stripped.There was no delay in patient care or extended surgery time due to this instrument.A pre-order was placed to replace these instruments.This report is for one (b)(4).This is report 1 of 2 for complaint blade/screw guide sleeve.

Event Description

The event happened preoperatively; there was no patient involvement.

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: a1: no patient involvement b3: event date added.B5: event description updated.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.

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.H3, h6: a product investigation was conducted.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 blade/screw guide sleeve was unable to be disassembled from its mating device.The threads of the device are stripped causing it to be stuck to its mating device.No other defect was found on it.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.A dimensional inspection was not performed for the blade/screw guide sleeve as it is not applicable to the complaint condition.A functional test was performed by trying to disassemble the devices but is was not possible.The complaint condition was able to be replicated.Additionally it was found yellow markings missing.The device exhibits damage consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.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 blade/screw guide sleeve contribute to the complained device issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h6: a manufacturing record evaluation was performed for the finished device product code: 03.037.017-us.Lot number: 43p8425.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 05/03/2020.Manufacturing site: jabil bettlach.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: BLADE/SCREW GUIDE SLEEVE
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH)Q; muracherstrasse 3; bettlach CO 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 17161751
• MDR Text Key: 317548123
• Report Number: 8030965-2023-07665
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982070333
• UDI-Public: (01)10886982070333
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• 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
• Device Operator: Health Professional
• Device Model Number: 03.037.017
• Device Catalogue Number: 03.037.017
• Device Lot Number: 43P8425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 06/22/2023; 07/20/2023
• Supplement Dates FDA Received: 07/13/2023; 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BUTTRESS/COMPRESSION NUT