MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI MULTILOC SCREW LENGTH 38MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.019.038S

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/14/2022

Event Type  Injury  

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent surgery to treat humerus. The patient did not underwent unreasonable rehabilitation, but cut-out progressed as the patient progressed to 1 to 2 weeks after the initial surgery. According to surgeon the postoperative reduction was good. A revision surgery is not planned. No further information is available. This report is for one (1) 4. 5mm ti multiloc screw length 38mm-sterile. This is report 4 of 7 for complaint (b)(4).

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5MM TI MULTILOC SCREW LENGTH 38MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13765036
• MDR Text Key: 291714470
• Report Number: 8030965-2022-01616
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819430631
• UDI-Public: (01)07611819430631
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.019.038S
• Device Lot Number: 402P667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 03/15/2022 Patient Sequence Number: 1

Treatment

CASQUILLO-CIERRE MULTILOC P/HN/PHN MULTI; LOCKSCR Ø4 L26 F/NAILS TAN DBLUE; LOCKSCR Ø4 L26 F/NAILS TAN DBLUE; PHN MULTILOC Ø9.5 IZQ CAN L160 TAN; TORNILLO MULTILOC Ø4.5 L30 TAN; TORNILLO MULTILOC Ø4.5 L36 TAN