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

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device disposition is unknown.

Event Description

The manufacturer became aware of a study from (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 sonic pin.Within that publication, post- operative complications/ adverse events were reported which occurred between (b)(6) 2003 and (b)(6) 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.2 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.¿.

Event Description

The manufacturer became aware of a study from pa foot and ankle associates, allentown, pa.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 sonic pin.Within that publication, post- operative complications/ adverse events were reported which occurred between (b)(6) 2003 and (b)(6) 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.2 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.¿.

Manufacturer Narrative

Please note correction in section d4 the unknown catalog number was revised from unk sel to unk kiel.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.

• Brand Name: UNKNOWN SONICPIN
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8811276
• MDR Text Key: 151742191
• Report Number: 0009610622-2019-00551
• 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: 08/19/2019

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
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other