MAUDE Adverse Event Report: SYNTHES GMBH TIP FOR DHS/DCS IMPACTOR (338.28)

Catalog Number	338.26
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2023
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: e3: reporter is a j&j employee.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h4, h6: 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, during a dhs case over the past holiday weekend, after the lag screw a correctly implanted, the plate was then inserted over the lag screw.The plate was then malleted over the top to sit flush with the lateral cortex, upon malleting with the mallet and impactor, the plastic end of the impactor broke into two pieces.Once the piece (338.26) broke, the surgeon and resident agreed that the implant was perfectly placed and no further malleting was necessary.The procedure was successfully completed with no delay.No patient consequence was reported.No fragments were generated.This report is for one (1) tip for dhs/dcs impactor (338.28) 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.H3,h4,h6 the customer reported that the device 338.26, tip for dhs/dcs impactor (338.28), plastic end of the impactor broke into two pieces.The repair technician reported that portion of plastic broken off.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Due to the age of more than 10 years of the complained device a wear or use related root cause is the most likely reason of the complained malfunction.Per franchise complaint product investigation procedure 100673626 is for complaints for which a non-manufacturing related probable cause has been identified no manufacturing record evaluation is required.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: TIP FOR DHS/DCS IMPACTOR (338.28)
• Common Device Name: IMPACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18519488
• Report Number: 8030965-2024-00880
• Device Sequence Number: 6676410
• Product Code: HWA
• UDI-Device Identifier: 10886982193292
• UDI-Public: 10886982193292
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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 Expiration Date: 05/08/2019
• Device Catalogue Number: 338.26
• Device Lot Number: A4JV367
• 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: 12/26/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 74 YR
• Patient Sex: Female