MAUDE Adverse Event Report: SYNTHES GMBH 4.0MM TI CANCELLOUS BONE SCREW FULLY THREADED/18MM; PASSER

Catalog Number 406.018S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

Additional product code hwc.Complainant part is not expected to be returned for manufacturer review/investigation.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.If additional information is made available, the investigation will be updated as applicable device history lot: sterile - part, part: 406.018s, lot: 6l76896, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: march 12, 2020, expiry date: march 01, 2030.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: non - sterile - part, part: 406.018, lot: 4l98953, manufacturing site: (b)(4), release to warehouse date: july 12, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the reported complaint condition were identified.This non-conformance is not relevant to the complaint condition because, nr-0126775 was an labeling issue.All labeling of this lot was reworked.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient was operated with an osteosynthesis on the inferior limbs in (b)(6) 2020.Since (b)(6) 2020, the patient had an allergy.No further information provided.This report is for one (1) 4.0mm ti cancellous bone screw fully threaded/18mm this is report 7 of 10 for complaint (b)(4).This complaint involves total 13 devices.Additional 03 devices are reported under the related complaint (b)(4).

Event Description

The adverse event was discovered one (1) month after the primary surgery.There is no revision surgery scheduled at this time.

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.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: 4.0MM TI CANCELLOUS BONE SCREW FULLY THREADED/18MM
• Type of Device: PASSER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10938152
• MDR Text Key: 219354509
• Report Number: 8030965-2020-09344
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 07611819134256
• UDI-Public: (01)07611819134256
• Combination Product (y/n): N
• PMA/PMN Number: K925351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 406.018S
• Device Lot Number: 6L76896
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/30/2020
• Patient Sequence Number: 1
• Treatment: CANCELLOUSSCR Ø4 FULL-THR L14 TI; CANCELLOUSSCR Ø4 L50/15 TI; CORTSCR Ø3.5 SELF-TAP L14 TI; CORTSCR Ø3.5 SELF-TAP L14 TI; CORTSCR Ø3.5 SELF-TAP L14 TI; CORTSCR Ø3.5 SELF-TAP L26 TI; CORTSCR Ø3.5 SELF-TAP L45 TI; CORTSCR Ø3.5 SELF-TAP L55 TI; LCP ONE-THIRD TUBULAR PLATE 3.5, 6 HOLES; CANCELLOUSSCR 4 FULL-THR L14 TI; CANCELLOUSSCR 4 L50/15 TI; CORTSCR 3.5 SELF-TAP L14 TI; CORTSCR 3.5 SELF-TAP L14 TI; CORTSCR 3.5 SELF-TAP L26 TI; CORTSCR 3.5 SELF-TAP L45 TI; CORTSCR 3.5 SELF-TAP L55 TI; CORTSCR Ø3.5 SELF-TAP L14 TI; LCP ONE-THIRD TUBULAR PLATE 3.5, 6 HOLES
• Patient Outcome(s): Required Intervention