MAUDE Adverse Event Report: SYNTHES PRODUKTIONS GMBH 4.5 TI MULTILOC SCREW LENGTH 22-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.019.022S
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.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 (b)(6) 2021, patient underwent a surgical procedure, while inserting an interlocking multliloc screw, the screw was too short.The surgeon continued to try to insert the multiloc screw possible stripping out the plastic insert of the multiloc humeral nail.The screw was pulled out of the bone and nail, and abandoned that screw hole procedure was completed successfully with a five(5) minutes surgical delay.No patient consequence reported.Concomitant device reported: unk - insertion instruments: trauma (part # unknown; lot # unknown; quantity: 1).This report is for one (1) 4.5 ti multiloc screw length 22-sterile.This is report 2 of 2 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: part: 04.019.022s-us.Lot: l962462.Manufacturing site: grenchen.Release to warehouse date: 06 july 2018.Expiration date: 01 june 2028.A manufacturing record evaluation was performed for the finished article lot 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.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.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: 4.5 TI MULTILOC SCREW LENGTH 22-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES PRODUKTIONS GMBH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• MDR Report Key: 12495709
• Report Number: 9612488-2021-00012
• Device Sequence Number: 3596973
• Product Code: HSB
• UDI-Device Identifier: 10886982089656
• UDI-Public: (01)10886982089656
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.019.022S
• Device Catalogue Number: 04.019.022S
• Device Lot Number: L962462
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/15/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7 TI MULTILOC HUMERAL NAIL RT/CANN/240-S; UNK - INSERTION INSTRUMENTS: TRAUMA; 7 TI MULTILOC HUMERAL NAIL RT/CANN/240-S; UNK - INSERTION INSTRUMENTS: TRAUMA
• Patient Age: 77 YR
• Patient Weight: 49