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

Model Number	312.77
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
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.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 or Problem 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).
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.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
• Common Device Name: 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
• Report Number: 8030965-2023-01611
• Device Sequence Number: 6845139
• Product Code: FZX
• UDI-Device Identifier: 10886982187949
• UDI-Public: (01)10886982187949
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Company Representative
• Initial Reporter Occupation: Other
• 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 Model Number: 312.77
• Device Catalogue Number: 312.77
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 02/18/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 4.5 HDLESS COMPRESSION SCR GRAPHIC CASE
• Patient Sex: Unknown