MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DHS®/DCS® COUPLING SCREW; EXTRACTOR

Catalog Number 338.310

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

Patient Problem Foreign Body In Patient (2687)

Event Date 09/14/2019

Event Type  Injury  

Manufacturer Narrative

Without a lot number the device history records review could not be completed.Product was not returned.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 that on (b)(6) 2019 a dhs material broke and one part was retained in the patient.This report is for one (1) dhs®/dcs® coupling screw.This is report 1 of 2 for (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.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: DHS®/DCS® COUPLING SCREW
• Type of Device: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9167141
• MDR Text Key: 166745688
• Report Number: 8030965-2019-69148
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819022133
• UDI-Public: (01)07611819022133
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 09/17/2019

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: 338.310
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 11/27/2019
• Supplement Dates FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR