MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM TI HEADLESS COMPRESSION SCR/LONG THRD/40MM-STERILE; SCREW,FIXATION,BONE

Catalog Number 04.226.750S

Device Problem Entrapment of Device (1212)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).Device is not distributed in the united states but is similar to device marketed in the usa.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 on an unknown date that the screw was broke at the junction 1/3 proximal and 2/3 distal while it¿s retrieval.2/3 of the device remains inside the patient¿s scapula.The device was implanted in the patient shoulder on (b)(6) 2017.There was no reported surgical delay and patient outcome.This is report 02 of 02 of (b)(4).

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.Part: 04.226.750s, lot: 2775543, manufacturing site: bettlach, release to warehouse date: 07.Sep.2011, expiry date: 01.Aug.2021.A manufacturing record evaluation was performed for the finished device lot number, 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.1924 is an additional patient to code 3191.Code 3191 used to capture medical device removal.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: 4.5MM TI HEADLESS COMPRESSION SCR/LONG THRD/40MM-STERILE
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9770568
• MDR Text Key: 192716363
• Report Number: 8030965-2020-01539
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819982390
• UDI-Public: (01)07611819982390
• Combination Product (y/n): N
• PMA/PMN Number: K080943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: 04.226.750S
• Device Lot Number: 2775543
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2020
• Patient Sequence Number: 1
• Treatment: HCS Ø4.5 SELF-DRILL CANN L40/16 TAN; HCS Ø4.5 SELF-DRILL CANN L50/20 TAN
• Patient Outcome(s): Required Intervention