MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN HALF PIN (5 MM); IMPLANT

Catalog Number UNK_SEL

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Injury (2348); Post Operative Wound Infection (2446)

Event Date 03/01/2007

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 a study from (b)(6).The title of this report is ¿the use of external fixators in the definitive stabilisation of the pelvis in polytrauma patients: safety, efficacy and clinical outcomes¿ which is associated with the stryker ¿hoffman ii external fixation¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from march 2007 to december 2012.It was not possible to ascertain specific device/patient 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 38 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses infection with pin loosening followed by revision.2 out of 2 cases.The report states: ¿in two cases the infection was combined with clinical loosening of the pins and the management included removal of the pins and administration of oral antibiotics.¿.

Manufacturer Narrative

New information in section h6 (patient code).

Event Description

The manufacturer became aware of a study from leeds general infirmary, united kingdom.The title of this report is ¿the use of external fixators in the definitive stabilisation of the pelvis in polytrauma patients: safety, efficacy and clinical outcomes¿ which is associated with the stryker ¿hoffman ii external fixation¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from (b)(6) 2007 to (b)(6) 2012.It was not possible to ascertain specific device/patient 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 38 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses infection with pin loosening followed by revision.2 out of 2 cases.The report states: ¿in two cases the infection was combined with clinical loosening of the pins and the management included removal of the pins and administration of oral antibiotics.¿.

• Brand Name: UNKNOWN HALF PIN (5 MM)
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9716916
• MDR Text Key: 190687734
• Report Number: 0008031020-2020-00412
• Device Sequence Number: 1
• Product Code: HTY
• 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: 03/27/2020

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: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention