MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE; PLATE, BONE

Catalog Number 805.604.04S

Device Problems Break (1069); Device-Device Incompatibility (2919)

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

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, during an unknown procedure, the four (4) screws were discovered as defective and broken.The screws were unable to fit in the device hole for assembly.No further information provided.This report is for one (1) 1.5mm rapid resorbable cortex screw 4mm-sterile this is report 4 of 4 for (b)(4).

Manufacturer Narrative

Additional narrative: initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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.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.

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.H10: additional narrative: b5, d4, h3, h4, h6: part 805.604.04s, lot 8l45813: manufacturing site: werk bio oberdorf.Release to warehouse date: october 05, 2021.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: 1.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BIO OBERDORF (CH); eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13889571
• MDR Text Key: 288899408
• Report Number: 8030965-2022-01853
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819748385
• UDI-Public: (01)07611819748385
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K062789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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 Catalogue Number: 805.604.04S
• Device Lot Number: 8L45813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: RAPIDSORB CORTSCR Ø1.5 L4 4U