MAUDE Adverse Event Report: SYNTHES GMBH DHS/DCS COUPLING SCREW; EXTRACTOR

Model Number 338.31

Device Problems Contamination /Decontamination Problem (2895); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

(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: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j sales representative.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 Description

It was reported, that on an unknown date, that the wood handled instruments are leaving a stain/residue when they are peel-packed and sterilized.There were no patient consequence.This complaint involves fourteen (14) devices.This report is for one (1) dhs/dcs coupling screw.This is report 4 of 14 for (b)(4).

Event Description

The initial complaint was reviewed and found not reportable.Upon further investigation it was identified that the product 338.31 reported under 8030965-2023-04630 was incorrect product.The correct product is spine product 388.31.Since 388.31 is a spine product, this complaint is reported under spine operating company under 8030965-2023-05975.

• Brand Name: DHS/DCS COUPLING SCREW
• Type of Device: EXTRACTOR
• 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: 16738317
• MDR Text Key: 313344375
• Report Number: 8030965-2023-04630
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982193322
• UDI-Public: (01)10886982193322
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• 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
• Device Operator: Health Professional
• Device Model Number: 338.31
• Device Catalogue Number: 338.31
• Device Lot Number: A4EF588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 4.0MM HEXAGONAL SCREWDRIVER.; CANNULATED 4.0MM HEXAGONAL SCREWDRIVER.; DHS/DCS COUPLING SCREW.; GOUGE W/10 L205/90.; LARGE HEXAGONAL SCREWDRIVER LONG.; LARGE HEXAGONAL SCREWDRIVER.; LARGE HEXAGONAL SCREWDRIVER.; SCRDRIVER-HEX-SMALL W/HOLD-SLEEVE.; SCRDRIVER-HEX-SMALL W/HOLD-SLEEVE.; SCRDRIVER-HEX-SMALL W/HOLD-SLEEVE.; SCRDRIVER-HEX-SMALL W/HOLD-SLEEVE.; SDDRIVE SCREWDRIVER T8.; SDDRIVE SCREWDRIVER T8.; STR BALL SPIKE FOR LOW PRO PELVIC SYS.