MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STERNAL LOCK-PL 2.4 STRAIG 20HO TI; PLATE, FIXATION, BONE

Catalog Number 460.023

Device Problems Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Additional product codes: hwc, jdq.(b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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 (b)(6) as follows: the patient underwent an osteosynthesis of a sternoclavicular dislocation with a blocked sternum system, dr.(b)(6) decides to place the emergency rod upside down and it was explained that the system is indicated for sternum closure and that rod blocks and secures the plate.But the system fails, and the patient must be re-operated at 8 days, on that occasion an anatomical clavicle plate with lateral extension was used on each side, from the sternum to the clavicle.It also deters to removal of osteosynthesis material and new osteosynthesis.Patient condition is unknown.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity # unknown).This is report 1 for 1 (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.E1: phone number reported as (b)(6).H3, h4: part number: 460.023, lot number: h762738, part manufacture date: 22-oct-2018, manufacturing location: elmira, part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of ti sternal locking straight plate- 20 holes product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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: STERNAL LOCK-PL 2.4 STRAIG 20HO TI
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9158735
• MDR Text Key: 167773462
• Report Number: 8030965-2019-69072
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819796201
• UDI-Public: (01)07611819796201
• Combination Product (y/n): N
• PMA/PMN Number: K093772
• 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: 09/14/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 460.023
• Device Lot Number: H762738
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 10/31/2019
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention