MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN FIXOS COMPRESSION SCREW (Ø 4.0 MM/Ø 5.0 MM/Ø 7.0 MM) IMPLANT

Catalog Number UNK_SEL

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Impaired Healing (2378)

Event Date 10/01/2015

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 post market clinical follow-up (pmcf) from (b)(6). The title of this report is ¿a retrospective data collection of the fixation, correction, and stabilization of small and long bones in adult and adolescent patients with the use of cannulated, headless, compression screws¿ which was published in july-2019 and is associated with the stryker fixos screw system. Within that publication, post-operative complications/ adverse events were reported, which occurred between october-2015 to april-2019. It was not possible to ascertain specific device catalog 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 7 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses nonunion. 4 out of 6 cases. The report states,¿there were 7 adverse events reported out of 32 cases, however, none were device-related. The most common adverse event was nonunion, which was seen in 6 (19%) of cases. [¿]although 19% of cases resulted in complications of nonunion, this cannot be attributed to the fixation alone. ¿.

• Brand Name: UNKNOWN FIXOS COMPRESSION SCREW (Ø 4.0 MM/Ø 5.0 MM/Ø 7.0 MM)
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8902109
• MDR Text Key: 155850930
• Report Number: 0008031020-2019-01063
• Device Sequence Number: 1
• Product Code: KWA
• 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

• Type of Report: Initial
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer 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 Treatment Data

Date Received: 08/16/2019 Patient Sequence Number: 1