MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM IMF SCREW SELF-DRILLING 12MM; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 201.932S

Device Problem Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/17/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Part of the screw remained in the patient¿s bone; device not considered explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 Description

Device report from synthes reports an event in the (b)(6) as follows: the patient name cannot be shared for confidentiality.The patient was afro-caribbean and had dense bone.The bone was not pre drilled.The screw broke in the maxilla.The correct instrumentation was used with the screw.The screw fractured the patient, with the broken screw half left in situ.I have been given the other screw half.This report is for one (1) imf screw ø2 l12 sst.This is report 1 of 1 for complaint (b)(4).

Event Description

It was noted the procedure was completed successfully with no surgical delay.The broken fragment remained in the patient and the patient was informed.

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, d9, d10, h4, h3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.H3, h6: sterile part: part: 201.932s, lot: 8l90223, manufacturing site: werk selzach, supplier: (b)(4), release to warehouse date: december 15, 2021, expiration date: december 01, 2031, a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part: part: 201.932, lot: 547p934, manufacturing site: mezzovico, release to warehouse date: december 09, 2021, a manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the imf screw ø2 l12 sst was found the screw tip broken.The broken fragment was not returned.No evidence for embedded device was not provided.A dimensional inspection for the imf screw ø2 l12 sst was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the imf screw ø2 l12 sst would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed the drawings reflecting the current revision was reviewed.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: 2.0MM IMF SCREW SELF-DRILLING 12MM
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14136376
• MDR Text Key: 289451105
• Report Number: 8030965-2022-02497
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819747807
• UDI-Public: (01)07611819747807
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 201.932S
• Device Lot Number: 8L90223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 04/22/2022; 06/01/2022
• Supplement Dates FDA Received: 05/20/2022; 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS
• Patient Outcome(s): Required Intervention