MAUDE Adverse Event Report: SYNTHES GMBH 9.5MM/7.0MM PROTECTION SLEEVE; GUIDE, SURGICAL, INSTRUMENT

Model Number 312.77

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 01/18/2023

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.Additional narrative: device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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 (b)(6) 2023 animal health did an in-house order for a 4.5mm headless compression screw set.When the set arrived an animal health employee configured the set.It was determined the 9.5/7.0mm protection sleeve does not fit the 4.5mm headless compression screw assembly tray of the graphic case as it should.It appears either the protection sleeve handle is too long or the assembly tray bracket was position incorrectly or made to the wrong specification, not allowing the protection sleeve to properly fit as shown in the technique guide or on the etching of the assembly tray.It was unknown, if there was a patient involvement.This report is for one (1) 9.5mm/7.0mm protection sleeve.This is report 1 of 1 for complaint (b)(4).

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.A1, a2, a3, a4: device used in a veterinary case - no patient information will be reported.H6: a manufacturing record evaluation cannot be performed due to lot number being unknown.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from the received image(s).Visual analysis of the photo revealed that 9.5mm/7.0mm protection sleeve does not appears to be properly secured into the assembly bracket of the tray.A dimensional or functional inspection cannot be assessed though a photo investigation or without the physical sample.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for 9.5mm/7.0mm protection sleeve.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.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: 9.5MM/7.0MM PROTECTION SLEEVE
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16337239
• MDR Text Key: 309176379
• Report Number: 8030965-2023-01611
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982187949
• UDI-Public: (01)10886982187949
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 312.77
• Device Catalogue Number: 312.77
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 4.5 HDLESS COMPRESSION SCR GRAPHIC CASE