MAUDE Adverse Event Report: SYNTHES GMBH LONG SMALL HEXAGONAL SCREWDRIVER

Model Number	388.31
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
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.B3: event year reported as 2023, exact date of event is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.G3: the report for this complaint was submitted on april 20, 2023 under manufacturer report number 8030965-2023-05035 for trauma product 338.31.Upon further investigation it was identified that the product 338.31 reported under this report 8030965-2023-05035 was incorrect product.The correct product is spine product 388.31.Since 388.31 is a spine product, this complaint needs to be reported again under spine operating company.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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 an unknown date the wood handled instruments were leaving a stain/residue when they are peelpacked and sterilized.There was no patient or procedure involvement.This report is for one (1) long small hexagonal screwdriver.This is report 2 of 2 for complaint (b)(4).This complaint is related to (b)(4) and (b)(4).

• Brand Name: LONG SMALL HEXAGONAL SCREWDRIVER
• Common Device Name: SCREWDRIVER
• 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 16899031
• Report Number: 8030965-2023-05976
• Device Sequence Number: 20198393
• Product Code: HXX
• UDI-Device Identifier: 10705034772417
• UDI-Public: (01)10705034772417
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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

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: 388.31
• Device Catalogue Number: 388.31
• Device Lot Number: A4EF588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/09/2023
• 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
• Patient Sex: Unknown