MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN THREADED HALF PIN (3 MM); IMPLANT

Catalog Number UNK_SEL

Device Problems Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Non-union Bone Fracture (2369)

Event Date 01/01/2006

Event Type  Injury  

Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group.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.Device disposition is unknown.

Event Description

The manufacturer became aware of study from (b)(6).The title of this report is ¿clavicle lengthening by distraction osteogenesis for congenital clavicular hypoplasia: case series and description of technique¿ which is associated with the stryker ¿hoffman ii external fixator¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from 2006 to 2011.It was not possible to ascertain specific device details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 6 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses implant removal due to poor regenerate and risk of plastic deformation and fracture followed by revision surgery.3 out of 3 cases.The report states: ¿three clavicles (in patients 1, 2, and 4) required internal fixation with a 3.5-mm dynamic compression plate after fixator removal due to poor regenerate and risk of plastic deformation and fracture.¿.

Event Description

The manufacturer became aware of study from the royal national orthopaedic hospital, united kingdom.The title of this report is ¿clavicle lengthening by distraction osteogenesis for congenital clavicular hypoplasia: case series and description of technique¿ which is associated with the stryker ¿hoffman ii external fixator¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from 2006 to 2011.It was not possible to ascertain specific device details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 6 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses implant removal due to poor regenerate and risk of plastic deformation and fracture followed by revision surgery.3 out of 3 cases.The report states: ¿three clavicles (in patients 1, 2, and 4) required internal fixation with a 3.5-mm dynamic compression plate after fixator removal due to poor regenerate and risk of plastic deformation and fracture.¿.

Manufacturer Narrative

New information in section h6 (device code and patient code).

• Brand Name: UNKNOWN THREADED HALF PIN (3 MM)
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9702462
• MDR Text Key: 190764821
• Report Number: 0008031020-2020-00349
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• 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: 02/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention