MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN SONICPIN; IMPLANT

Catalog Number UNK_KIE

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

Patient Problems Unspecified Infection (1930); Thrombosis (2100)

Event Date 07/29/2008

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 pre-marketing clinical study report from (b)(6).The title of this report is ¿internal fixation of osteotomies for hallux valgus correction using sonic pins¿ which is associated with the stryker sonicpin.Within that publication, postoperative complications/ adverse events were reported which occurred between 5-may-2008 and 11-september-2008.It was not possible to ascertain specific device catalog from the study, 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 5 complaints were initiated retrospectively for adverse events mentioned in the study.This product inquiry addresses increased wbs and thrombocytes due to a splenectomy & dvt.

Event Description

The manufacturer became aware of a pre-marketing clinical study report from chirurgische gemeinschaftspraxis, bad schwartau, germany.The title of this report is ¿internal fixation of osteotomies for hallux valgus correction using sonic pins¿ which is associated with the stryker sonicpin.Within that publication, postoperative complications/ adverse events were reported which occurred between (b)(6) -2008 and (b)(6) 2008.It was not possible to ascertain specific device catalog from the study, 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 5 complaints were initiated retrospectively for adverse events mentioned in the study.This product inquiry addresses increased wbs and thrombocytes due to a splenectomy & dvt.

Manufacturer Narrative

Correction in section h6 (patient code).

• Brand Name: UNKNOWN SONICPIN
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9444035
• MDR Text Key: 178375335
• Report Number: 0009610622-2019-00960
• 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: 02/05/2020

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_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 85