MAUDE Adverse Event Report: SYNTHES GMBH 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAILS-STER; SCREW, FIXATION, BONE

Model Number	04.005.422S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent orif for proximal humerus fracture with the products in question.After opening the nail, the surgeon performs a dry check on the instrument table and confirms that the drill has passed through before inserting the nail into the body.He then inserted the guidewire for blade insertion as per the procedure manual, measured and inserted.Once it interfered with the nail, it was pulled back and reinserted.As the blade advanced along the guidewire, the screws in question were inserted distally over the device.When attempting to remove the device for end cap insertion after distal screw insertion, it was discovered that the blade and distal lateral stop screws were not in the nail.He then removed the blade and screws from the body and reinserted the nail.This time he inserted from the distal lateral stop screws and the proximal blade, so they were inserted with no problem.The blades were the same length, but the distal screws changed length.The screws in question are screws that could not be inserted through the device.The surgery was completed successfully within 30 minutes delay.No further information is available.This report is for a 4.0mm ti locking screw w/t25 stardrive 32mm f/im nails-ster.This is report 2 of 4 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Common device name: additional procode: hsb.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device evaluated by mfr: 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.
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.H4, h6: part: 04.005.422s.Lot: 7l34164.Manufacturing site: werk selzach.Release to warehouse date: 23 september 2020.Expiration date: 01 september 2030.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non sterile product code: 04.005.422.Non sterile lot: 69p7861.Manufacturing site: mezzovico.Release to warehouse date: 17 september 2020.A manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.D6: there is no date of implantation or date of explantation as the incident occurred intraoperatively.

• Brand Name: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAILS-STER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16378957
• Report Number: 8030965-2023-01880
• Device Sequence Number: 5898833
• Product Code: HWC
• UDI-Device Identifier: 10886982085351
• UDI-Public: (01)10886982085351
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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
• Operator of Device: Health Professional
• Device Model Number: 04.005.422S
• Device Catalogue Number: 04.005.422S
• Device Lot Number: 7L34164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• 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: LOCKSCR Ø4 L32 F/NAILS TAN DBLUE; UNK - NAIL HEAD ELEMENTS: DHS/DCS BLADE; UNK - NAILS
• Patient Sex: Unknown