MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI CANNULATED LOCKING SCREW 55MM; PLATE, FIXATION, BONE

Model Number	04.205.055
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent a removal surgery.During the surgery, the locking screw was too tight and could not be removed.The screw head got stripped, so the surgeon removed the other screws.Then, the surgeon removed the locking screw in question with the plate.The removal surgery was completed successfully without any delay.No further information is available.This report involves one unk - screws: locking: trauma.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: this report is for an unknown screws: locking: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter facility address: (b)(6).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.
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.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 further reported that the 5.0mm ti cannulated locking screw could not be removed from the ti tomofix medial high tibia plate.This report is for one (1) 5.0mm ti cannulated locking screw 55mm.
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.H10 additional narrative: h3, h4, h6 investigation summar 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 cann-lockscr ã¸5 l55 tan was received stuck in a one of the holes of the plate.The recess head was severely worn and stripped which could have been a result of implantation and explantation of the device.A dimensional inspection for the cann-lockscr ã¸5 l55 tan was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 cann-lockscr ã¸5 l55 tan would contribute to the complained device issue.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.Drawing/specifications reviewed? yes, reviewed.Dimensional inspection: n/a.Device history: manufacturing location: monument ; manufacturing date: 08-jan-2022; part number: 04.205.055, 5.0mm ti cannulated locking screw 55mm; lot number: 585p098 (non-sterile); lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, inspect turn, wobble broach, mill shaft threads / head threads / flutes and final inspection, met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 21039, tialnbri9.5; lot number: 73p4447; lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Inspection certificate test report supplied by perryman company dated 01-sep-2020 and certificate of test supplied to perryman by howmet corporation dated 19-dec-2019 were reviewed and determined to be conforming.Lot summary report dated 07-oct-2020 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: 5.0MM TI CANNULATED LOCKING SCREW 55MM
• Common Device Name: PLATE, FIXATION, BONE
• 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: 16090440
• Report Number: 8030965-2023-00066
• Device Sequence Number: 12414851
• Product Code: HRS
• UDI-Device Identifier: 10886982116376
• UDI-Public: (01)10886982116376
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 04.205.055
• Device Catalogue Number: 04.205.055S
• Device Lot Number: 585P098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 05/05/2023; 05/05/2023; 05/18/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/12/2023; 05/05/2023; 05/05/2023; 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TOMOFIXTIBHEADPL MED PROX 4HO TI.; UNK - PLATES: TRAUMA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown