| Brand Name | SYSTEM 9 STERNUM SAW |
|---|
| Common Device Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
|---|
| Manufacturer (Section D) |
| STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP |
| 1941 stryker way |
| portage MI 49002 |
|
|---|
| Manufacturer (Section G) |
| STRYKER INSTRUMENTS-KALAMAZOO |
| 4100 east milham avenue |
|
| kalamazoo MI 49001 |
|
|---|
| Manufacturer Contact |
|
colette
chung
|
| 1941 stryker way |
| portage, MI 49002
|
|
2693237700
|
|
|---|
| MDR Report Key | 18073292 |
|---|
| Report Number | 3015967359-2023-02439 |
|---|
| Device Sequence Number | 7815652 |
|---|
| Product Code |
HWE
|
| UDI-Device Identifier | 07613327467840 |
|---|
| UDI-Public | 07613327467840 |
|---|
| Combination Product (Y/N) | N |
|---|
| Initial Reporter State | MI |
|---|
| Initial Reporter Country | US |
|---|
| Number of Events Summarized | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Reporter Type |
Manufacturer
|
|---|
| Report Source |
Company Representative |
|---|
| Initial Reporter Occupation |
Other
|
|---|
| Type of Report
| Initial |
|---|
| Report Date (Section B) |
11/06/2023 |
|---|
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Is this an Adverse Event Report? |
No
|
|---|
| Is this a Product Problem Report? |
Yes
|
|---|
| Device Catalogue Number | 9207000000 |
|---|
| Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
|---|
| Date Returned to Manufacturer | 10/27/2023 |
|---|
| Type of Report(Section G) | Initial |
|---|
| Initial Date Received by Manufacturer | 11/01/2023 |
|---|
| Initial Report FDA Received Date | 11/06/2023 |
|---|
| Was Device Evaluated by Manufacturer? (Y/N) |
Yes
|
|---|
| Is the Device Labeled for Single Use? (Y/N) |
No
|
|---|
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N) |
No
|
|---|
| Usage of Device |
Reuse
|
|---|
| Patient Sequence Number | 1 |
|---|
| Patient Sex | Unknown |
|---|
|
|
