MAUDE Adverse Event Report: SYNTHES GMBH IMF SCREW Ø2 L12 SST; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 201.932S

Device Problems Break (1069); Entrapment of Device (1212)

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

Event Date 04/04/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in the (b)(6) as follows: screw has broken in a patient, the patient did not have hard bone.No other information at present.This is the second one from the same batch other complaint reported under (b)(4).This report is for one (1) imf screw ø2 l12 sst.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.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.

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: h3, h6: part # 201.932s.Lot # 8l90223.Manufacturing site: werk selzach.Release to warehouse date: 15 dec 2021.Expiration date: 01 dec 2031.Supplier: (b)(4).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.B1, b2.H1 h6: health effect impact code.H6: health effect clinician code 2402 used to capture inury.

• Brand Name: IMF SCREW Ø2 L12 SST
• 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: 14252866
• MDR Text Key: 290457362
• Report Number: 8030965-2022-02835
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention