MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM CANNULATED SCREW PARTIALLY THREADED/40MM; SCREW,FIXATION,BONE

Model Number	205.040
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is jnj representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported on an unknown date that cannulated screw was found with fully stripped head.It was unknown how and when it was happened.It was also unknown if there was any procedure or patient involvement.This complaint involves one (1) device.This report is for (1) 3.5mm cannulated screw partially threaded/40mm.This report is 1 of 1 for (b)(4).
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.H6: investigation summary: 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.Device history lot: a dhr file for part #205.040, lot #40p2919 combination could not be found in the synthes systems.If more information becomes available this dhr review will be revisited.Device was used for treatment, not diagnosis.If additional information is made available, the investigation will be updated as applicable.
Event or Problem Description
Update: concomitant devices reported: cannscr ø3.5 l40/13 sst - part #205.040, lot #2l84635.
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.E1 g1 h4, h6: part: 205.040 lot:40p2919 manufacturing site: grenchen release to warehouse date: 03 february 2020 a manufacturing record evaluation was performed for the part: 205.040, lot: 40p2919, 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.

• Brand Name: 3.5MM CANNULATED SCREW PARTIALLY THREADED/40MM
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10970854
• Report Number: 8030965-2020-09525
• Device Sequence Number: 702837
• Product Code: HWC
• UDI-Device Identifier: 10886982146892
• UDI-Public: (01)10886982146892
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K161616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020

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: 205.040
• Device Catalogue Number: 205.040
• Device Lot Number: 40P2919
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/23/2020; 01/19/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/15/2021; 02/01/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CANNSCR Ø3.5 L40/13 SST