MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER LOCKING SCREW

Catalog Number UNK SHOULDER LOCKING SCREW

Device Problems Fracture (1260); Difficult to Advance (2920)

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

Event Date 01/24/2023

Event Type  malfunction  

Event Description

It was reported to me today by at (b)(6) hospital that the patient he performed a reverse shoulder replacement on on the (b)(6) 2023 at (b)(6) hospital using the delta xtend system, has a small fragment of a screw in the joint.I attended this case but my notes in sales force have been quarantined so i cant get them.They tried to put in a locking screw but was unable to advance it fully.On trying to remove it the screw broke and he had to try using the trauma set to remove it.After several unsuccessful attempts to he decided to leave the broken part in the glenoid /metaglene baseplate.However on xray he noted that a small fragment of the broken proximal end is in the joint.He isn¿t concerned about this and will monitor on follow ups with the patient.There is no product to return and lot number of screw is unknown.The case was on the (b)(6) 2023 not the (b)(6) 2023.Notes from salesforce: ¿left reverse shoulder replacement using standard metaglene, 24mm and 42mm locking screws and 1 x 18mm non locking screw.Wasn't happy with fixation of inferior screw (24mm locking).Drilled and measured for 36mm posterior locking screw but wasn't happy with angle so tried to remove.Used opace screw removal kit unsuccessfully and top of screw broke off.He considered option of removing other 3 screws and metaglene to try to remove remaining screw part but decided to leave insitu with the 3 screws¿.

Manufacturer Narrative

Product complaint #: (b)(4).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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The above information has been reviewed the device catalog number is unknown; therefore, udi is unavailable.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.The information received, will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers, the investigation closed.Should additional information be received, the information will be reviewed.And the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre) was not possible, because the required lot code was not provided.Added: h6 (health effect: impact code).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

Additional information received indicated that there was a delay of approximately 15 minutes in the procedure whilst the surgeon was trying to remove the screw from the metaglene.

• Brand Name: UNKNOWN SHOULDER LOCKING SCREW
• Type of Device: LOCKING SCREW
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr; warsaw, IN 46580 ; 3035526892
• MDR Report Key: 17060629
• MDR Text Key: 317212510
• Report Number: 1818910-2023-11544
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2023

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: UNK SHOULDER LOCKING SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 06/06/2023; 06/09/2023
• Supplement Dates FDA Received: 06/06/2023; 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER NON-LOCKING SCREW