MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN SONICPIN; IMPLANT

Catalog Number UNK_KIE

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

Patient Problem Organ Dehiscence (2502)

Event Date 10/01/2003

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 (b)(6) foot and ankle associates, (b)(6).The title of this report is ¿resorbable polymer pin inserted with ultrasound activated bone welding technique compared with a screw for osteotomy fixation in the reverse l bunion correction¿ and is associated with stryker sonicpin.Within that publication, post- operative complications/ adverse events were reported which occurred between october 2003 and february 2017.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, 21 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses dehiscence.3 out of 6 cases.The study reports: ¿there were 6 dehiscence events treated successfully in the clinic [¿].None of these patients had lack of fixation purchase intraoperatively and none of these patients required additional internal fixation of any kind.None of these patients required an additional surgical procedure.¿.

• Brand Name: UNKNOWN SONICPIN
• 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: 8816984
• MDR Text Key: 152022598
• Report Number: 0009610622-2019-00554
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/23/2019

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: 07/05/2019
• Initial Date FDA Received: 07/23/2019
• 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): Other