MAUDE Adverse Event Report: SYNTHES GMBH INSERTION HANDLE RADIOLUCENT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	03.233.005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Pro-code: hwc.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j sales representative.Investigation summary: product was not returned.Based on the information available.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 unknown date, an event occurred where we did a nail plate combo, the first plate was used the central fixed angle screw hole did not lock into the plate, we ended up taking out the plate and using a second one of a longer length.We assembled the nail and then inserted the lm / ml screw holes and the drill bit missed the nail, i¿m not entirely sure if it was due to the notch of the tka replacement or because of the screws from the plate diverging the drill bit.The 13mm sleeve was bent during the case as well from pushing and the entry reamer was stuck in the sleeve.(b)(4) is related to (b)(4).(b)(4) captures post-op.(b)(4) captures intra-op.This complain involves five (5) devices.This report is for one (1) insertion handle radiolucent.This is report 3 of 5 for complaint (b)(4).

• Brand Name: INSERTION HANDLE RADIOLUCENT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 16250646
• Report Number: 8030965-2023-01029
• Device Sequence Number: 12400177
• Product Code: HSB
• UDI-Device Identifier: 10886982288356
• UDI-Public: (01)10886982288356
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 03.233.005
• Device Catalogue Number: 03.233.005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/26/2023
• 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 VA-LCP CRVD COND PL/10 HOLE/230/LFT.; 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT.; AIMING ARM RADIOLUCENT.; CONNECTING SCREW.
• Patient Sex: Unknown