MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN APEX PIN; IMPLANT

Catalog Number UNK_SEL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Loss of Range of Motion (2032); No Code Available (3191)

Event Date 12/01/1993

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) hospital, (b)(6).The title of this report is ¿complications of temporary and definitive external fixation of pelvic ring injuries¿ which is associated with the stryker hoffman external fixation system.Within that publication, postoperative complications/ adverse events were reported which occurred from december 1993 to november 2002.It was not possible to ascertain specific device catalog or patient details 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 94 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses impingement of the fixator on the skin.2 out of 8 cases.

Manufacturer Narrative

New information in section b2, h6 patient and device codes.

Event Description

The manufacturer became aware of a study from frenchay hospital, bristol, uk.The title of this report is ¿complications of temporary and definitive external fixation of pelvic ring injuries¿ which is associated with the stryker hoffman external fixation system.Within that publication, postoperative complications/ adverse events were reported which occurred from december 1993 to november 2002.It was not possible to ascertain specific device catalog or patient details 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 94 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses impingement of the fixator on the skin.2 out of 8 cases.

• Brand Name: UNKNOWN APEX PIN
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9333368
• MDR Text Key: 166768954
• Report Number: 0008031020-2019-01739
• Device Sequence Number: 1
• Product Code: JDW
• 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: 02/19/2020

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: 10/21/2019
• Initial Date FDA Received: 11/17/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other