MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN APEX PIN (3-MM HALF-PINS) 2; IMPLANT

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nerve Damage (1979)

Event Date 05/18/2011

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.

Event Description

The manufacturer became aware of a literature published by department of orthopaedics, university hospital balgrist, zurich in switzerland.The title of this report is ¿radial nerve disruption following application of a hinged elbow external fixator¿ which is associated with the stryker ¿dynamic joint distractor ii¿ system.The article can be found at 10.2106/jbjs.J.00436.This report includes research done on 3 patients in the year of 2011.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses disruption of the radial nerve for which external fixator was removed 5 weeks postoperatively.The report states patient fell while skiing and sustained a complex posterior dislocation of the right, dominant elbow with a comminuted radial head fracture.Closed reduction and application of a long arm cast was performed at a local hospital.Immediately after reduction, redislocation of the elbow in the cast was noted, and the patient was referred to a trauma center, where two additional unsuccessful attempts at closed reduction and cast immobilization were carried out.Six weeks after the injury, she had a persistent dislocation.As the fixator pins (3-mm half-pins) could not be placed through the posterior incision, they were placed percutaneously.Immediately postoperatively, a complete radial nerve palsy was noted, and electrodiagnostic testing four weeks after the surgery raised a high suspicion for a severe nerve injury.The radial nerve was explored during the removal of the external fixator five weeks postoperatively.A complete disruption of the nerve was found at the level of the distal humeral pin.Secondary reconstruction three months later to avoid potential contamination from the fixator pins and to avoid risking the elbow stiffness that can result from the elbow immobilization that is necessary following nerve reconstruction and tendon transfer.Three months postoperatively, the elbow was stable with a 100 degree arc of elbow motion and nearly full forearm rotation.

Event Description

The manufacturer became aware of a literature published by department of orthopaedics, university hospital balgrist, zurich in switzerland.The title of this report is ¿radial nerve disruption following application of a hinged elbow external fixator¿ which is associated with the stryker ¿dynamic joint distractor ii¿ system.The article can be found at 10.2106/jbjs.J.00436.This report includes research done on 3 patients in the year of 2011.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses disruption of the radial nerve for which external fixator was removed 5 weeks postoperatively.The report states: patient fell while skiing and sustained a complex posterior dislocation of the right, dominant elbow with a comminuted radial head fracture.Closed reduction and application of a long arm cast was performed at a local hospital.Immediately after reduction, redislocation of the elbow in the cast was noted, and the patient was referred to a trauma center, where two additional unsuccessful attempts at closed reduction and cast immobilization were carried out.Six weeks after the injury, she had a persistent dislocation.As the fixator pins (3-mm half-pins) could not be placed through the posterior incision, they were placed percutaneously.Immediately postoperatively, a complete radial nerve palsy was noted, and electrodiagnostic testing four weeks after the surgery raised a high suspicion for a severe nerve injury.The radial nerve was explored during the removal of the external fixator five weeks postoperatively.A complete disruption of the nerve was found at the level of the distal humeral pin.Secondary reconstruction three months later to avoid potential contamination from the fixator pins and to avoid risking the elbow stiffness that can result from the elbow immobilization that is necessary following nerve reconstruction and tendon transfer.Three months postoperatively, the elbow was stable with a 100 degree arc of elbow motion and nearly full forearm rotation.

Manufacturer Narrative

Correction: please refer to h6 conclusion code.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible and no additional information will be requested to the customer as this serves for trending purpose.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.Based on the investigation, no definitive relation could be established between the product and the reported failure adverse consequence.However, the root cause of the event has been identified by the authors of the article.Indeed, the authors clearly indicate that percutaneous placement of the humeral pins caused the damage to the nerve: - "the course of the radial nerve around the distal part of the humerus is complex, and the radial nerve is at risk for injury during an operative procedure in this area" - "in the present report, we presented three cases of complete radial nerve disruption due to percutaneous placement of the humeral pins." based on the preceding statements, we can conclude that the event is procedure-related & not device-related.If any further information is provided, the investigation report will be updated.

• Brand Name: UNKNOWN APEX PIN (3-MM HALF-PINS) 2
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10891949
• MDR Text Key: 218971192
• Report Number: 0008031020-2020-02521
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention