MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN SONICPIN 2.0 MM DIAMETER, LENGTH 22-26 MM; IMPLANT

Catalog Number UNK_KIE

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

Patient Problems Edema (1820); Impaired Healing (2378)

Event Date 05/05/2008

Event Type  Injury  

Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided.If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly.Device evaluated by mfr: device disposition is unknown.

Event Description

The manufacturer became aware of a study from university hospital (b)(6).The title of this report is ¿ultrasonically assisted anchoring of biodegradable implants for chevron osteotomies ¿ clinical evaluation of a novel fixation method¿ and is associated with the stryker sonic pin.Within that publication, post-operative complications/ adverse events were reported which occurred between may 5th to september 11th, 2008.It was not possible to ascertain specific device or patient information from the article; 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, 3 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses unusual bone healing pattern.The study reports, "one case (3.3%) showed an unusual bone healing pattern without clinical correlation.The mri revealed signs of edema around the regularly shaped implanted pin and cortical bone defect dorsally at three months follow-up.A radiograph was taken six months postoperatively, which showed complete bony healing with interosseous sclerosis.".

• Brand Name: UNKNOWN SONICPIN 2.0 MM DIAMETER, LENGTH 22-26 MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8841782
• MDR Text Key: 152694472
• Report Number: 0009610622-2019-00577
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2019

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: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention